Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1054241

FEI Number

1000112877

Entity Name

DeRoyal Industries, Inc.

City/State/Country

NEW TAZEWELL, TN, US

Establishment Address

1135 HWY. 33 SOUTH, NEW TAZEWELL, TN 37825, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

DEROYAL INDUSTRIES, INC. (Owner Number: 1044833)

Owner / Operator Contact Address

200 DEBUSK LN., --, Powell, TN 37849, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drape, Surgical - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Laparoscopic Accessories, Gynecologic - DeRoyal Kit, I.V. Start - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal Wax, Bone - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Introducer, Catheter - DeRoyal Instrument, Ligature Passing & Knot Typing - DeRoyal Culture Media, Non-Selective and Non-Differential - DeRoyal Amniotome - DeRoyal Stocking, Elastic - DeRoyal Drape, Surgical - DeRoyal Drape, Surgical - DeRoyal Gauze/Sponge, Internal - DeRoyal Incubator, Neonatal - Warmer, Infant Radiant - DeRoyal Injector and Syringe, Angiographic - DeRoyal Syringe, Piston - DeRoyal Urinary Drainage Collection Kit, for Indwelling Catheter - DeRoyal Hood, Surgical - DeRoyal Neurosurgical Paddie - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Injector and Syringe, Angiographic - DeRoyal Tubing, Fluid Delivery - DeRoyal Medical Glove, Specialty - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Table, Cystometric, Electric - DeRoyal Drape, Patient, Ophthalmic - DeRoyal Needle, Suturing, Disposable - DeRoyal Surgeon's Gloves - DeRoyal Caliper, Ophthalmic - DeRoyal Syringe, Piston - DeRoyal Dressing, Wound, Drug - DeRoyal Foley Catheter Kit (excludes HIV testing) - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Tourniquet, Nonpneumatic - DeRoyal Nerve Block Tray (Kit) - DeRoyal System, X-Ray, Fluoroscopic, Image-Intensified - DeRoyal Suture Kit - DeRoyal Wire, Guide, Catheter - DeRoyal BLOOD PRESSURE CUFF - DeRoyal Instrument, Surgical, Disposable - DeRoyal Stopcock, IV Set - DeRoyal Speculum, Vaginal, Metal - DeRoyal Accessories, Catheter - DeRoyal Dilator, Vessel, Surgical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Drape, Surgical - DeRoyal Mask, Surgical - DeRoyal Cystotome - DeRoyal Laparoscope General and Plastic Surgery - DeRoyal Basin, Emesis - DeRoyal Dilator, Urethral Syringe, Balloon Inflation - DeRoyal Catheter, Urological - DeRoyal Blood Pressure Cuff - DeRoyal Thermometer, electronic, clinical - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Injector and Syringe, Angiographic - DeRoyal Absorber, Saliva, Paper - DeRoyal Ear, Nose, and Throat Surgical Tray - DeRoyal Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal Scissors, Medical, Disposable - DeRoyal Stethoscope, Esophageal, with Electrical Conductors - DeRoyal Sponge, Ophthalmic - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Surgical Table Cushion - DeRoyal Syringe, Piston - DeRoyal HRX Arthroscope GEI Electrosurgical, Cutting & coagulation & Accessories - DeRoyal Gown, Surgical - DeRoyal Razor, Surgical - DeRoyal Forceps - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Accessories, Operating-Room, Table (Kit) - DeRoyal Fiber, Medical, Absorbent - DeRoyal Applicator, Absorbent Tipped, Sterile - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Light, Surgical, Accessories - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Set, Administration, Intravascular - DeRoyal Catheter and Tip, Suction - DeRoyal Pack, Hot or Cold, Water Circulating - DeRoyal Tape and Bandage, Adhesive - DeRoyal Electrocautery, Gynecologic (and Accessories) - DeRoyal Suture, Surgical, Absorbable, Polydioxanone - DeRoyal Handle, Scalpel - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Wax, Bone - DeRoyal FZT - Cutter, Surgical - DeRoyal Stethoscope, Esophageal, with Electrical Conductors - DeRoyal Electrosurgical Cutting & Coagulation Accessories - DeRoyal System, irrigation, Urological - DeRoyal Hemostat - DeRoyal Syringe, Piston - DeRoyal Burn Kit without Drug - DeRoyal Blood and Urine Collection Kit (Excludes HIV Testing) - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Catheter, Urological - DeRoyal Anesthesia Conduction Kit - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Patch, Pledget and Intracardiac, PTTP, PTFE, Polypropylene - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Set, Administration, Intravascular - DeRoyal Connector, Catheter - DeRoyal Tourniquet Kit - DeRoyal Guide, Needle, Surgical - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Filter, Bacterial, Breathing - Circuit - DeRoyal Instrument, Cranioplasty Material Forming - DeRoyal Protector, Skin Pressure - DeRoyal Syringe, balloon inflation - DeRoyal Dressing, Wound, Occlusive - DeRoyal Set, Administration, Intravascular - DeRoyal Clamp, Vascular - DeRoyal Sling, Arm - DeRoyal Catheter, Urological - DeRoyal Grounding Pad Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Set, Administration, Intravascular - DeRoyal Pad, Alcohol, Device Disinfectant - DeRoyal Container, Empty, for Collection & Processing of Blood & Blood Components - DeRoyal Dressing, Wound, Drug - Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Drape, Surgical - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Monitor, Line Isolation - DeRoyal Snare, Surgical - DeRoyal Accessories, Catheter - DeRoyal Gown, Surgical - DeRoyal Body Fluid Barrier Kit - DeRoyal Collector, Urine, (and Accessories) for Indwell Cath/ Tray, Catheteriz, Sterile Urethral, w/wo Catheter (kit)- DeRoyal Sigmoidoscope and Accessories, Flexible/Rigid - DeRoyal Marker, Skin - DeRoyal Gauze, Internal, X-ray Detectable - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Clip, Vascular - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Clamp, Vascular - DeRoyal Joint, Shoulder, External Limb Component - DeRoyal Central Venous Catheter Dressing Change Kit - DeRoyal Injector and Syringe, Angiographic - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Joint, Elbow, External Limb Component, Mechanical - DeRoyal Container, I V - DeRoyal Hemostat, Surgical - DeRoyal Wire, Guide, Catheter - DeRoyal Anesthesia Conduction Kit - Needle, Conduction, Anesthetic (w/wo Introducer) - DeRoyal Syringe, Piston - Needle, Hypodermic, Single Lumen - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Drape, Surgical - DeRoyal Accessory, Surgical Apparel - DeRoyal Coagulator, Laparoscopic, Unipolar (and accessories) - DeRoyal Suture Removal Kit - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Laparoscope, Gynecologic (and accessories) - DeRoyal Unit, Suction Operatory - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal Tissue Adhesive for the Topical Approximation of Skin - DeRoyal Set, Administration, Intravascular - DeRoyal Holder, Needle, Gastroenterologic - DeRoyal Drape, Surgical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Device, Occlusion, Umbilical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Specula, Ophthalmic - DeRoyal Dressing, Wound, Drug, Lavage, Jet - DeRoyal Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal Set, administration, intravascular - DeRoyal Catheter, Straight - DeRoyal Sound, Uterine - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Dressing, Wound, Drug - DeRoyal Holder, Needle; Orthopedic - DeRoyal Bandage, Liquid, Skin Protectant - DeRoyal Dressing, Wound, Drug - DeRoyal Kit, Pelvic Exam - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Catheter, Intravascular, Therapeutic, short-term less than 30 days - DeRoyal Cesarean Section Kit - DeRoyal Gown, Surgical - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Catheter, Continuous Irrigation - DeRoyal Drape, Surgical - DeRoyal Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed - DeRoyal Syringe, piston - DeRoyal Suture, Nonabsorbable, Synthetic, Polypropylene - DeRoyal Syringe, Piston - DeRoyal Gauze/Sponge, Internal - DeRoyal Speculum, Vaginal, Nonmetal - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Catheter and Tip, Suction - DeRoyal Connector, Catheter - DeRoyal Set, Administration, Intravascular - DeRoyal Cover, Limb - DeRoyal Bag, Urine Collection, Leg, For External Use, Non-Sterile - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal Suture, Nonabsorbable, Synthetic, Polyethylene - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Dressing Change Tray - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Cannula, Ophthalmic - DeRoyal Tube, Aspirating, Flexible, Connecting - DeRoyal Set, Administration, Intravascular - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Catheter, Coude - DeRoyal Hysterectomy Kit - DeRoyal Tray, Surgical, Instrument - DeRoyal Container, I. V. - DeRoyal Medical Glove, Specialty - DeRoyal Syringe, Piston - DeRoyal Gown, Surgical - DeRoyal Gown, Surgical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Medical Glove, Specialty - DeRoyal Agent, Absorbable Hemostatic, Non-Collagen Based - DeRoyal Catheter, Peritoneal - DeRoyal Applier, Surgical, Clip - DeRoyal Accessory Equipment, Cardiopulmonary Bypass - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Bandage, Cast - DeRoyal Dressing, Wound, Occlusive - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Clean-up Kit - DeRoyal Component, Traction, Non-Invasive - DeRoyal Set, Administration, Intravascular - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Unit, Filter, Membrane - DeRoyal Electrocautery, Gynecologic (and Accessories) - DeRoyal Clip, Implantable - DeRoyal Streamway Drape, Surgical - DeRoyal General Purpose Dental Tray - DeRoyal Condom - DeRoyal Labor and Delivery Kit - DeRoyal Catheter, Irrigation - DeRoyal Suture, Nonabsorbable, Synthetic, Polypropylene - DeRoyal Drape, surgical - DeRoyal Lubricant, Patient - DeRoyal Clip, Implantable - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Staple, Implantable - DeRoyal Cannula, Surgical, General & Plastic Surgery - DeRoyal Laryngoscope, Endoscope - DeRoyal Bandage, Liquid - DeRoyal Dispenser, Liquid Medication - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Skin Prep Tray (Kit)- DeRoyal Gynecological Laparoscopic Kit - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Sponge, Ophthalmic - DeRoyal Set, Administration, Intravascular - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Stopcock, IV Set - DeRoyal Catheter, Intravascular, Therapeutic, Short-Term less than 30 days - DeRoyal Gastroenterology - Urology - DeRoyal Gown, Surgical - DeRoyal Scalpel, One-Piece - DeRoyal Drape, Surgical - DeRoyal Lavage, Jet - DeRoyal Set, Administration, Intravascular - DeRoyal Drape, Surgical, Exempt - DeRoyal Punch, Surgical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Hook, Tracheal - DeRoyal Cannula, Manipulator/Injector, Uterine - DeRoyal Gauze/Sponge, Internal - DeRoyal Trephine, Manual, Ophthalmic - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Eye Tray - DeRoyal Needle, Conduction, Anesthetic (W/WO Introducer)- DeRoyal Jelly, Lubricating, For Transurethral Surgical Instrument - DeRoyal Clamp, Surgical, General & Plastic Surgery - DeRoyal Depressor, Tongue, Non-Surgical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Container, Specimen, Non-Sterile - DeRoyal Minor Surgical Procedures Tray - DeRoyal Catheter, Intravascular, Therapeutic, Short-term less than 30 days - DeRoyal Insufflator, Laparoscopic - DeRoyal Catheter, Urological - DeRoyal System, Thermal Regulating - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Drape, Surgical - DeRoyal Stapler, Skin - DeRoyal Camera, Surgical and Accessories - DeRoyal Blade, Saw, General & Plastic Surgery, Surgical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Probe - DeRoyal Tubing, Noninvasive - DeRoyal Injector and Syringe, Angiographic - DeRoyal Set, Administration, Intravascular - DeRoyal Surgeon's Gloves - DeRoyal Gown, Surgical - DeRoyal Drape, Surgical - DeRoyal Drape, Surgical - DeRoyal Catheter, Retention Type, Balloon - DeRoyal Retractor - DeRoyal Introducer, Catheter - DeRoyal Dressing, Wound, Drug - DeRoyal Drape, Surgical - DeRoyal Catheter, Urological (antimicrobial) and Accessories - DeRoyal Cardiovascular Surgical Instruments Tray - DeRoyal Pap Smear Kit - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Trap, Sterile Specimen - DeRoyal Sheet, Burn - DeRoyal Dressing, Wound, Drug - DeRoyal Wrap, Sterilization - DeRoyal Cotton, Roll - DeRoyal Lift, Patient, Non-AC-Powered - DeRoyal Set, Administration, Intravascular - DeRoyal Garment, Protective, for Incontinence - DeRoyal Clip, Implantable - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Catheter, Urological - DeRoyal Pneumoperitoneum Needle - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Clip, Implantable - Add Forceps, Ophthalmic - DeRoyal System, Imaging, Pulsed Echo, Ultrasonic - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Scissors, General, Surgical - DeRoyal Dilator, Vessel, for Percutaneous Catheterization - DeRoyal Injector and Syringe, Angiographic - DeRoyal Set, Administration, Intravascular - DeRoyal Gown, Surgical - DeRoyal Set, Administration, Intravascular - DeRoyal CLAMP - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Dressing, Wound and Burn, Occlusive - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal Angiography/Angioplasty Kit - DeRoyal Hook, Surgical, General & Plastic Surgery - DeRoyal Tubes, Vacuum Sample, with Anticoagulant - DeRoyal Needle, Aspiration and Injection, Disposable - DeRoyal Pad, Menstrual, Unscented - DeRoyal Arthroscope - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Oxygenator, Cardiopulmonary Bypass - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Syringe, Piston - DeRoyal Syringe, Piston - DeRoyal Balloon, Epistaxis - DeRoyal Catheter, Angioplasty, Peripheral, Transluminal - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-02-18
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2016-01-15
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-01-15
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-01-15
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-01-15
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-01-15
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2016-01-15
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-01-15
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2012-11-02
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2015-12-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-02-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-02-27
MTJ	Wax, Bone	Unknown	Class U	N/A	2024-05-24
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2015-09-22
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2005-08-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-08-28
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2004-12-09
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-07-14
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2001-08-03
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2015-09-25
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-23
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-23
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2010-01-29
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2012-04-25
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2012-04-25
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-04-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2015-11-23
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-05-29
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2016-01-27
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2016-01-15
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2016-06-03
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-08-03
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-11-01
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2024-05-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-08
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-01-08
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-01-08
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-12-02
MMZ	Table, Cystometric, Electric	Gastroenterology, Urology	Class 2	876.4890	2024-10-17
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2015-09-17
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1997-11-12
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-01-28
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-09-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-05-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-11-06
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2018-01-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-01-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-24
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2005-09-28
OGJ	Nerve Block Tray	Anesthesiology	Class 2	868.5140	2016-05-17
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2012-09-04
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2016-02-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-06-06
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2006-06-20
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-02-21
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2024-05-23
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2024-05-24
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2004-06-23
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2025-04-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2013-08-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-23
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2016-01-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-06-06
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2001-05-16
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2015-08-25
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2015-08-25
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-12-13
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2016-07-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-09-10
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-12-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-11-01
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2023-11-14
OGR	Ear, Nose, And Throat Surgical Tray	Ear, Nose, Throat	Class 1	874.4420	2016-09-22
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2024-12-13
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1998-08-07
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2020-04-28
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2024-12-04
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2025-08-26
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2006-07-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-08-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-01-27
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-29
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-09-20
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-08-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-08-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-08-22
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2012-09-28
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2006-08-22
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2004-06-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-04
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2015-09-22
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2006-08-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2012-09-20
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	1997-02-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-04-04
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2013-01-24
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2024-08-26
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-09-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-01-18
MTJ	Wax, Bone	Unknown	Class U	N/A	2016-02-08
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-04-19
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2016-10-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-11-15
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-12-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-12-13
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2006-08-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-07-18
OJJ	Burn Kit Without Drug	General, Plastic Surgery	Class 1	878.4022	2015-12-10
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2016-05-17
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2001-08-03
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2023-09-29
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2024-01-16
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-19
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2022-08-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-05-24
OJS	Tourniquet Kit	General, Plastic Surgery	Class 1	878.5900	2016-02-08
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-01-27
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-12-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-05-11
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-11-14
HBX	Instrument, Cranioplasty Material Forming	Neurology	Class 1	882.4500	2024-11-12
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-07-27
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2012-10-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-12-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2011-05-05
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2006-07-27
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2015-11-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-01-05
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2012-09-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2016-02-08
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2009-12-30
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2021-07-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-07-21
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-12-13
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-09-10
DRI	Monitor, Line Isolation	Cardiovascular	Class 1	870.2620	2025-01-02
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-09-28
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-05-24
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-02-10
OKH	Body Fluids Barrier Kit	General, Plastic Surgery	Class 2	878.4040	2016-02-08
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2015-11-20
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2015-11-20
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2012-09-26
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2006-08-22
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2024-08-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-13
DSS	Clip, Vascular	Cardiovascular	Class 2	870.3250	2025-04-10
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2025-06-09
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2015-11-09
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	1992-10-28
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	Class 2	880.5200	2015-12-10
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-08-28
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2016-08-31
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-05-29
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2024-05-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-11-09
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-04
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2012-09-04
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-05-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-05-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-11-10
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-05-24
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2013-08-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2005-08-25
HFG	Coagulator, Laparoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2024-12-13
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2015-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-05-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-06
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2024-12-13
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2016-01-13
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-12-24
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2025-05-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-13
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2012-09-17
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-01-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-12-24
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-08-22
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	1997-02-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-05-24
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-05-17
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-07-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-07-17
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2012-09-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-19
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2023-10-16
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2024-05-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-01-23
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-07-20
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2024-07-31
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2016-02-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-07-28
MLT	Pelvic Exam Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-05-17
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2013-08-26
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-07-25
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2016-03-07
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-01
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-05-24
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-11-09
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2023-04-19
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2024-01-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-11-09
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2024-08-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-12-13
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2015-09-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-05
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-12-13
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-09-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-07-08
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2024-07-08
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2001-08-03
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2012-09-28
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2009-08-21
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-08-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	1994-01-04
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2015-12-10
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2020-11-19
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-01-12
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2004-11-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-26
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2022-09-20
OJF	Hysterectomy Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-05-17
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-05-16
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-01-15
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-05-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-12-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-03-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-05-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-05-29
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2022-08-17
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2005-10-25
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2024-01-18
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	1997-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2005-08-08
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-05-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-20
PWU	Clean-Up Kit	General Hospital	Class 1	880.6890	2021-08-11
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2006-08-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-06-17
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2022-08-15
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2024-10-17
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2012-11-02
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-12-13
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2025-05-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-05-30
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2024-01-12
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2012-09-17
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-03-07
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2005-04-20
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-01-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2017-02-22
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2024-06-17
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-08-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-11-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-05-23
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-01-19
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-01-20
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2024-06-25
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2005-08-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2016-03-07
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2016-03-07
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2022-08-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-05-23
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2015-09-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-12-13
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2024-05-23
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-08-27
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-05-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-29
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2006-08-22
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2013-09-05
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2011-12-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-05-23
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-01
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-04-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2024-06-06
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2024-12-13
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2012-09-21
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-18
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2024-12-13
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2017-07-31
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2016-01-13
FHX	Jelly, Lubricating, For Transurethral Surgical Instrument	Gastroenterology, Urology	Class 2	876.1500	2011-06-28
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-23
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2001-08-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-24
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2006-08-22
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2025-06-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-01-14
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2024-12-13
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2024-12-13
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-09-17
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2024-12-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-28
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-24
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2022-04-06
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	1997-02-12
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2005-06-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
HXB	Probe	Orthopedic	Class 1	888.4540	2026-01-13
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-12-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-03-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-10
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2024-05-23
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-05-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-30
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-24
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-02-10
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-05-24
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2006-08-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-01-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-07-23
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-09-10
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-08-06
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2024-08-06
OFA	Cardiovascular Surgical Instruments Tray	Cardiovascular	Class 1	870.4500	2021-05-24
OHL	Pap Smear Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-03-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-23
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2025-04-23
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2004-12-09
SEL	Securement Wound Dressing For Reduction Of Infection	Unknown	Class U	N/A	2024-12-13
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-06-14
EFN	Cotton, Roll	Dental	Class 1	872.6050	2004-10-15
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-12-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-01-13
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-01-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2015-11-09
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-12-13
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2016-06-22
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2016-06-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-07-01
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2024-05-23
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-05-23
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-08-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-02-08
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2023-07-11
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2023-07-11
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-12-09
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2012-09-04
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-03-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-04
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-11-09
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2006-08-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-05-23
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-12-13
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2024-05-23
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2016-03-07
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-18
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2012-09-17
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-05-12
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2012-09-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-12-02
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2004-06-23
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-12-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-09-04
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2016-01-13
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-09-04

Official Correspondent

Elizabeth Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEROYAL INDUSTRIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008583452	DeRoyal Industries, Inc.	Powell, TN, US
1051550	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
1057404	DeRoyal Industries, Inc.	POWELL, TN, US
1034876	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
3021190810	DePre, LLC	Powell, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2009	Surgical Specialties Corp	2	3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1054241. Last updated year: 2026. Please use registration number 1054241 when referencing this establishment in official correspondence.