Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1060680

FEI Number

1000208624

Entity Name

DeRoyal Industries, Inc.

City/State/Country

NEW TAZEWELL, TN, US

Establishment Address

1703 Highway 33 S, NEW TAZEWELL, TN 37825, US

Establishment Type(s)

Repack or Relabel Medical Device

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

Apparatus, Traction, Non-Powered - DeRoyal Catheter and Tip, Suction - DeRoyal Joint, Knee, External Brace - DeRoyal System, Thermal Regulating - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Cannula, surgical, General & Plastic Surgery - DeRoyal Needle, Suturing, Disposable - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Component, External, Limb, Ankle/Foot - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Splint, Hand, and Components - DeRoyal WRIST Orthosis, Cervical - DeRoyal Dressing, Compression - DeRoyal Syringe, Piston - DeRoyal Orthosis, Cervical - Thoracic, Rigid - DeRoyal Cannula, Surgical, General & Plastic Surgery - DeRoyal Sling, Arm - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Syringe, balloon inflation - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Dispenser, Liquid Medication - DeRoyal Shoe, Cast - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Bag, Intestine - DeRoyal Stimulator, Nerve, Transcutaneous, For Pain Relief - DeRoyal Set, Administration, Intravascular - DeRoyal Orthosis, Limb Brace - DeRoyal Aid, Transfer - DeRoyal Culture Media, Non-Selective and Non-Differential - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Blood and Urine Collection Kit (Excludes HIV Testing) - DeRoyal Injector and Syringe, Angiographic - DeRoyal Thermometer, electronic, clinical - DeRoyal Insoles, Medical - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Support, Patient Position - DeRoyal Dressing, Wound and Burn, Occlusive - DeRoyal System, Thermal Regulating - DeRoyal Light, Surgical, Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Laparoscopy Kit - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Stopcock, IV Set - DeRoyal Kit, I.V. Start - DeRoyal Stapler, Skin - DeRoyal Sponge, Ophthalmic - DeRoyal Tape and Bandage, Adhesive - DeRoyal Joint, Elbow, External Limb Component, Mechanical - DeRoyal Razor, Surgical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Device, Occlusion, Umbilical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Jelly, Lubricating, For Transurethral Surgical Instrument - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal System, Thermal Regulating - DeRoyal Accessories, Operating-Room, Table (Kit) - DeRoyal Bottle, Collection, Vacuum - DeRoyal Garment, Protective, for Incontinence - DeRoyal Urinary Drainage Collection Kit, for Indwelling Catheter - DeRoyal Drape, Surgical, Exempt - DeRoyal Tape, Measuring, Rulers and Calipers - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Anti Fog Solution and Accessories, Endoscopy - DeRoyal Mask, Surgical - DeRoyal Pneumoperitoneum Needle - DeRoyal Orthosis, Corrective Shoe - DeRoyal Suture Removal Kit - DeRoyal Drape, Surgical - DeRoyal Orthosis, Lumbo-Sacral - DeRoyal Dressing, Wound, Drug - DeRoyal Bandage, Elastic - DeRoyal Lavage, Jet - DeRoyal Container, Specimen, Non-Sterile - DeRoyal Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal Scalpel, One-Piece - DeRoyal Cover, Barrier, Protective - DeRoyal Exerciser, Non-Measuring - DeRoyal Accessories, Cleaning Brushes, for Endoscope - DeRoyal Instrument, Surgical, Disposable - DeRoyal Dressing, Wound, Collagen - DeRoyal Tray, Surgical, Instrument - DeRoyal Stimulator, Nerve, Transcutaneous, For Pain Relief - DeRoyal Set, Administration, Intravascular - DeRoyal Stocking, Medical Support (For General Medical Purposes) - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Transducer, Ultrasonic, Diagnostic - BS Medical Tech Industry Central Venous Catheter Dressing Change Kit - DeRoyal Gauze/Sponge, Internal - DeRoyal Handle, Scalpel - DeRoyal Tubing, Pressure and Accessories - DeRoyal Tube, Aspirating, Flexible, Connecting - DeRoyal Pack, Hot or Cold, Reuseable - DeRoyal Dilator, Urethral Syringe, Balloon Inflation - DeRoyal Joint, Ankle, External Brace - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal Adaptor, Grooming - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Balloon, Epistaxis - DeRoyal Stocking, Elastic - DeRoyal Tube, Feeding - DeRoyal Electrosurgical, cutting & coagulation & accessories - DeRoyal Cover, Limb - DeRoyal Syringe, piston - DeRoyal Tray, Surgical - DeRoyal Bag, Ice - DeRoyal Dressing, Wound, Drug - DeRoyal Neurosurgical Paddie - DeRoyal Bandage, Cast - DeRoyal Tubing, Pressure and Accessories - DeRoyal Insufflator, Laparoscopic - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Grounding Pad Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Accessory, Surgical Apparel - DeRoyal Dressing, Wound, Occlusive - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Lubricant, Patient - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Laparoscopic Accessories, Gynecologic - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Needle, Catheter - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal General surgery tray - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Device, Transfer, Patient, Manual - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	1992-10-28
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2012-09-20
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2006-06-20
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2015-11-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-03-28
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-10-24
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1997-11-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	1991-04-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-08-03
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2006-06-20
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2006-06-20
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2004-12-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-05-19
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2017-04-27
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-01-19
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2006-07-27
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-08-28
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2012-10-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2005-08-25
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2006-06-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-09-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2012-11-02
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2012-11-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-05-22
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2006-06-20
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2012-08-27
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-07-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-09-04
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2016-05-17
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-04-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-09-10
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2012-11-02
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-12-02
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2005-08-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-01-30
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2015-11-09
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2015-09-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-03-13
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2016-03-07
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2015-09-22
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2017-11-01
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2015-12-10
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2022-04-06
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2015-09-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-04-04
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2016-08-31
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-09-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-09-05
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	1997-02-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
FHX	Jelly, Lubricating, For Transurethral Surgical Instrument	Gastroenterology, Urology	Class 2	876.1500	2011-06-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-05-23
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2014-04-23
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2012-09-28
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2004-10-19
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-01-13
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2015-11-23
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-01
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2006-08-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-28
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2009-08-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-10-26
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2016-06-22
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2016-06-22
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2006-06-20
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2015-12-10
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-01-02
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2006-06-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-11-06
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-08-09
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2011-12-30
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2006-08-22
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2012-09-25
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2006-08-22
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2011-09-19
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	1994-11-10
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-02-08
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-02-21
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2014-09-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-05-16
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2019-01-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-11-09
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2013-03-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-12-16
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	Class 2	880.5200	2015-12-10
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2010-01-29
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-09-17
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2012-09-20
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2004-11-03
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2001-08-03
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2015-08-25
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2015-08-25
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2005-08-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2012-09-17
ILW	Adaptor, Grooming	Physical Medicine	Class 1	890.5050	2015-09-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2016-01-13
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2015-09-25
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2012-11-16
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2022-07-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-07-18
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2001-08-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-11-09
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2001-02-06
KYR	Bag, Ice	General Hospital	Class 1	880.6050	1992-10-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-07-20
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2016-01-27
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2005-08-08
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2004-11-03
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2013-05-22
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2021-02-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-01-05
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2005-08-25
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-12-09
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2004-06-23
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2015-09-17
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2024-02-19
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2012-11-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-09-22
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-02-28
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2006-08-22
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-09-10
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2016-03-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-27
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2018-11-01
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2009-08-21

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1060680. Last updated year: 2026. Please use registration number 1060680 when referencing this establishment in official correspondence.