Convertors de Mexico S. de R.L. de C.V

FDA Device Registration & Listing · CD.JUAREZ Chihuahua, MX · Registration 9616088

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616088
FEI Number
3002902735
Entity Name
Convertors de Mexico S. de R.L. de C.V
City/State/Country
CD.JUAREZ Chihuahua, MX
Establishment Address
C. ARCADIA 1580, COL. TERRAZAS DEL VALLE, CD.JUAREZ Chihuahua CP 32599, MX
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Cardinal Health 200, LLC (Owner Number: 9028292)
Owner / Operator Contact Address
3651 Birchwood Drive, --, Waukegan, IL 60085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stainless Steel Tongue Cleaner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPM Cover, Limb Physical Medicine Class 1 890.3025 1994-05-23
PYC Paracentesis Tray General, Plastic Surgery Class 1 878.4200 2018-07-02
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2007-04-20
OJU Skin Prep Tray General, Plastic Surgery Class 1 878.4800 2011-06-27
PYF Sterile Puncture Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 1999-08-04
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2010-08-10
OKY Cytology Kit Obstetrics/Gynecology Class 2 884.4530 2011-11-14
OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric) Anesthesiology Class 1 868.5240 2011-09-20
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2011-11-09
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2011-07-07
PVW Pudendal Anesthesia Kit Obstetrics/Gynecology Class 2 884.5100 2018-06-06
PVT Maternity Kit Obstetrics/Gynecology Class 1 884.5435 2018-06-06
OGB Caudal Anesthesia Kit Anesthesiology Class 2 868.5140 2011-11-09
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 1999-08-04
PPG Urinary Drainage Collection Kit Gastroenterology, Urology Class 2 876.5130 2018-04-30
OGK Orotracheal Intubation Guide Kit Anesthesiology Class 2 868.1400 2011-11-09
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-04-26
PXJ Umbilical Catheter Insertion Tray General Hospital Class 2 880.5200 2018-06-06
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2007-04-26
GAO Suture, Nonabsorbable General, Plastic Surgery Class 2 878.4495 2021-05-14
OFE Central Venous Blood Pressure Kit Cardiovascular Class 2 870.1140 2011-06-27
OHZ Urine Transport Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2011-11-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2013-01-23
PEZ Central Venous Catheter Dressing Change Kit General Hospital Class 2 880.5200 2018-03-15
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2011-06-27
MCY Wound Dressing Kit General Hospital Class 2 880.5075 2011-11-11
PXS Cholecystectomy Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-08-04
NYE Fixture Mount Kit Dental Class 1 872.3980 2011-11-09
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2009-05-06
LDQ N/A N/A Class N/A N/A 2012-03-09
OJA Intravenous Extension Tubing Set General Hospital Class 2 880.5440 2013-01-29
OER Angioscopic Valvulotome Kit Cardiovascular Class 2 870.1650 2011-11-09
PWO Blood Administration Kit General Hospital Class 2 880.5440 2018-06-06
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2007-04-26
OJR Vacuum Powered Body Fluid Collection Kit General, Plastic Surgery Class 2 878.4780 2011-11-11
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2001-08-10
PVO Lumbar Drainage Catheter Kit Neurology Class 2 882.5550 2018-06-06
OJS Tourniquet Kit General, Plastic Surgery Class 1 878.5900 2011-11-11
OFU Spinal Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2011-11-10
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2009-06-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-03-20
MLS Labor And Delivery Kit Obstetrics/Gynecology Class 2 884.4530 2011-09-01
OII Arthrogram Tray Radiology Class 2 892.1650 2011-06-27
PPP Disposable Joint Aspiration/Injection Kit General, Plastic Surgery Class 1 878.4800 2018-05-10
PWT Chemotherapy Spill Clean-Up Kit General Hospital Class 1 880.6250 2025-12-02
KIZ Dish, Tissue Culture Hematology Class 1 864.2240 2009-03-30
PVS Fetal Blood Sampling Kit (Excludes Hiv Testing) Obstetrics/Gynecology Class 2 884.1560 2018-06-06
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 1995-04-03
GBS Catheter, Ventricular, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2013-01-31
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2009-07-15
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2009-06-15
OGA Brachial Plexus Anesthesia Kit Anesthesiology Class 2 868.5140 2011-11-09
PSI Perineal Irrigation Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
OJT Aspiration Tray General, Plastic Surgery Class 1 878.4800 2011-11-10
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2020-08-06
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-12-19
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2007-04-20
PYD Pelviscopy Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
PPF Urinary Irrigation Kit Gastroenterology, Urology Class 2 876.5130 2018-04-30
PPR Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures Orthopedic Class 2 888.1100 2018-06-05
OFJ Lead Introducer Kit Cardiovascular Class 2 870.1340 2011-11-09
PRT Gastric Irrigation And Aspiration Kit Gastroenterology, Urology Class 2 876.5980 2018-06-05
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 1996-05-01
OFV Regional Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
PXG Spill Kit General Hospital Class 1 880.6890 2018-06-06
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 1996-07-05
PVM Endoscopic Ventricular Catheter Placement Kit Neurology Class 2 882.4100 2018-06-06
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2007-04-20
PSP Intracranial Pressure & Temperature Monitoring Kit Neurology Class 2 882.1620 2018-06-06
KYP Snake Bite Suction Kit General Hospital Class 1 880.5740 2011-11-14
PPB Foley Catheter Kit (Excludes Hiv Testing) Gastroenterology, Urology Class 2 876.5130 2018-04-20
PXX Incision Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-07-07
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2013-06-11
OFX General Purpose Dental Tray Dental Class 1 872.6640 2011-11-09
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2007-04-26
OGP Cricothyrotomy Kit Anesthesiology Class 2 868.5800 2011-11-09
PXB Percutaneous Introducer Kit General Hospital Class 2 880.5570 2018-06-06
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
LDQ N/A N/A Class N/A N/A 2012-01-27
OGS Myringotomy Procedure Kit Ear, Nose, Throat Class 2 874.3880 2011-11-09
PAD Chest Drainage Kit General Hospital Class 2 880.6740 2018-03-15
OKV Obstetrical Kit Obstetrics/Gynecology Class 2 884.4520 2011-06-27
GBQ Catheter, Continuous Irrigation General, Plastic Surgery Class 1 878.4200 2021-05-14
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2011-07-11
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2013-06-25
PYJ Ulcer Wound Tray General, Plastic Surgery Class 1 878.4014 2018-07-02
OKX Trocar Kit Obstetrics/Gynecology Class 2 884.1720 2011-11-14
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2010-07-02
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 1994-05-23
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2007-11-09
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2001-07-27
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 1995-08-02
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2017-03-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-03-20
FFP Dilator, Rectal Gastroenterology, Urology Class 1 876.5450 2011-11-10
OHE Forensic Evidence Sexual Assault Kit Obstetrics/Gynecology Class 2 884.1630 2011-11-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2006-05-12
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2018-03-14
OJW Shave Prep Kit General, Plastic Surgery Class 2 878.4370 2011-06-27
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2012-06-25
OEU Cardiopulmonary Bypass Catheter Kit Cardiovascular Class 2 870.4210 2011-11-09
OJG Neurological Tray Neurology Class 1 882.4525 2009-05-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2011-06-17
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2011-06-17
OHM Cesarean Section Tray Obstetrics/Gynecology Class 2 884.1720 2011-07-19
PVX Vaginal Examination Tray Obstetrics/Gynecology Class 2 884.4530 2018-06-06
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2011-04-14
OGF Glossopharyngeal Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
PWZ Mid-Stream Collection Kit General Hospital Class 1 880.6730 2019-06-28
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2011-11-10
EYC Catheter, Upper Urinary Tract Gastroenterology, Urology Class 2 876.5130 2013-01-23
MIA Needle, Spinal, Short Term Anesthesiology Class 2 868.5150 1999-06-23
OES Cardiac Catheterization Kit Cardiovascular Class 2 870.1200 2011-11-09
PPO Multi-Lumen Hemodialysis Catheterization Kit Gastroenterology, Urology Class 2 876.5540 2019-06-28
OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat Class 1 874.4420 2011-06-27
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2012-08-08
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 1977-12-31
NWI Electrosurgical Electrode Kit Gastroenterology, Urology Class 2 876.4300 2011-11-10
OJF Hysterectomy Kit Obstetrics/Gynecology Class 2 884.4530 2011-07-19
PRP Balloon Gastrostomy Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-05
OHR Catheter Care Tray Gastroenterology, Urology Class 2 876.5130 2011-11-10
OIA Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) Pathology Class 1 864.3250 2011-11-09
HTD Forceps General, Plastic Surgery Class 1 878.4800 2007-04-26
PSC Nasogastric-Gastrojejunal Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2007-04-20
PRW Gastrointestinal Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
PRY Gastrostomy Jejunostomy Feeding Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
PWY Lumbar Puncture Tray (Adult & Pediatric) General Hospital Class 2 880.5570 2018-06-06
PVV Paracervical Anesthesia Kit Obstetrics/Gynecology Class 2 884.5100 2018-06-06
PWU Clean-Up Kit General Hospital Class 1 880.6890 2018-06-06
MHW Dressing, Compression General Hospital Class 1 880.5075 2010-09-17
ERY Drape, Surgical, Ent General, Plastic Surgery Class 2 878.4370 2017-08-07
PKF D And C Tray Unknown Class N N/A 2016-01-21
OGT Oral Irrigation Kit Dental Class 1 872.6510 2011-11-09
OKU Emergency Obstetrical Kit Obstetrics/Gynecology Class 1 884.4520 2011-11-14
GAO Suture, Nonabsorbable General, Plastic Surgery Class 2 878.4495 2021-05-14
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2005-07-11
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-02-19
PSJ Rectal Dilator Kit Gastroenterology, Urology Class 1 876.5450 2018-06-06
EBO Denture Repair Kit Dental Class 2 872.3570 2011-11-09
PWM Admission Kit (Patient Utensil) General Hospital Class 1 880.6730 2018-06-06
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-04-26
HFX Clamp, Circumcision Obstetrics/Gynecology Class 2 884.4530 2009-07-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-04-29
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2009-06-25
GBQ Catheter, Continuous Irrigation General, Plastic Surgery Class 1 878.4200 2021-05-14
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2007-04-20
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2013-04-30
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2007-04-26
OGI Nasal Endotracheal Tube Holder Kit Anesthesiology Class 1 868.5770 2011-11-09
MPO Infant Heel Warmer (Chemical Heat Pack) Physical Medicine Class 1 890.5710 2008-02-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-01-24
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2013-01-24
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-05-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-19
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2011-11-10
OID Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) Microbiology Class 1 866.2900 2011-11-09
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2015-05-14
OFZ Blood Specimen Collection Kit (Excludes Hiv Testing) Anesthesiology Class 1 868.1100 2011-11-09
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2011-11-10
MLT Pelvic Exam Kit Obstetrics/Gynecology Class 2 884.4530 2011-09-13
POZ Biopsy Needle Kit Gastroenterology, Urology Class 2 876.1075 2018-03-19
PPE Nephroscope Set Gastroenterology, Urology Class 2 876.1500 2018-01-24
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2007-04-20
OEV Cardiopulmonary Resuscitation Aid Kit Anesthesiology Class 2 868.5915 2011-11-09
NXZ Dental Hygiene Kit Dental Class 1 872.6855 2011-11-09
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2009-05-15
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2013-07-17
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 1999-03-30
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2019-11-13
OHL Pap Smear Kit Obstetrics/Gynecology Class 2 884.4530 2011-11-14
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2006-05-18
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 1993-01-08
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2001-08-22
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2013-01-24
LRQ Tracheostomy And Nasal Suctioning Kit Unknown Class 1 N/A 2011-11-09
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2015-06-04
OGL Oxygen Administration Kit Anesthesiology Class 2 868.5655 2011-11-09
PXO Bone Marrow Biopsy Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2011-11-14
MUI Media, Coupling, Ultrasound Radiology Class 2 892.1570 2020-09-14
PZG Surgical Eye Tray Ophthalmic Class 1 886.4350 2018-07-02
EYX Drape, Pure Latex Sheet, With Self-Retaining Finger Cot General, Plastic Surgery Class 2 878.4370 2017-08-11
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2009-06-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-02-20
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 1999-02-12
OIC Blood Alcohol Kit (Excludes Hiv Testing) Clinical Toxicology Class 2 862.3040 2011-11-09
PXW Herniorraphy Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2016-04-14
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2011-09-19
OXQ Dressing Change Tray General Hospital Class 1 880.5075 2011-09-06
OGD Custom Anesthesia Tray Anesthesiology Class 2 868.5120 2011-11-09
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation Gastroenterology, Urology Class 2 876.5980 2012-10-12
OFL Percutaneous Sheath Introducer Kit Cardiovascular Class 2 870.1340 2011-11-09
PXI Thoracentesis Tray General Hospital Class 2 880.5570 2018-06-06
PQE Ostomy Care Kit Gastroenterology, Urology Class 1 876.5900 2018-06-05
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2005-09-06
PPJ Peritoneal Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5630 2018-05-10
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2009-06-30
LRS I.V. Start Kit General Hospital Class 2 880.5200 2011-09-01
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2017-12-05
PXD Prep Kit General Hospital Class 1 880.6250 2018-06-06
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2000-08-03
FLK Thermometer, Clinical Mercury General Hospital Class 2 880.2920 1997-03-18
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2002-05-07
PRZ Gastrostomy Tube Kit Gastroenterology, Urology Class 2 876.5980 2020-03-18
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2013-06-03
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2005-04-13
OIO Radiographic Contrast Tray Radiology Class 2 892.1680 2011-06-27
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2011-11-10
PPI Hemodialysis Tray (Not A Start/Stop Kit) Gastroenterology, Urology Class 2 876.5820 2018-04-30
OFR Tracheobronchial Suction Catheter Kit Anesthesiology Class 1 868.6810 2011-11-09
PXF Sitz Bath Kit General Hospital Class 1 880.6730 2018-06-06
PPC Male External Catheterization Kit (Excludes Hiv Testing) Gastroenterology, Urology Class 2 876.5130 2018-04-30
OGJ Nerve Block Tray Anesthesiology Class 2 868.5140 2011-09-06
OFW Restorative Instrument And Component Tray Dental Class 2 872.3690 2011-11-09
PPQ Transtibial Anterior Cruciate Ligament Kit Orthopedic Class 2 888.3040 2018-06-05
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2012-02-09
PKE Laparoscopic Cholecystectomy Kit General, Plastic Surgery Class 1 878.4800 2018-03-15
DRC Trocar Cardiovascular Class 2 870.1390 2007-04-26
HXB Probe Orthopedic Class 1 888.4540 2007-04-20
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2006-04-11
OFO Airway Suction Kit Anesthesiology Class 1 868.6810 2011-11-09
PXV General Purpose Instrument Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2011-11-09
OFC Catheter Introducer Kit Cardiovascular Class 2 870.1340 2011-11-09
PSB Nasogastric Feed Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
OHF Culdocentesis Kit Obstetrics/Gynecology Class 2 884.1640 2011-11-14
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2009-09-23
PPL Single Needle (Co-Axial Flow) Dialysis Kit Gastroenterology, Urology Class 2 876.5820 2018-05-10
PSA Laparoscopic Jejunostomy Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2007-04-20
OKI Emergency Response Safety Kit General, Plastic Surgery Class 2 878.4040 2011-11-11
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2006-02-13
OFN Winged Intravenous Catheterization Kit Cardiovascular Class 2 870.1200 2011-11-09
OIN Prostate Seeding Kit Radiology Class 2 892.5730 2011-11-14
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2007-04-20
PFU Tissue Processing Kit Unknown Class N N/A 2018-03-15
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-03-18
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 1995-04-03
FQM Bandage, Elastic General Hospital Class 1 880.5075 2007-04-26
OKF Body Fluid Disposal Kit General, Plastic Surgery Class 2 878.4040 2011-11-11
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2007-04-26
NYF Gingival Retraction Kit Dental Class 1 872.4565 2011-11-09
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2021-05-14
OKE Port Introducer Kit General Hospital Class 2 880.5965 2011-09-28
OFK Percutaneous Atrial Catheter Kit Cardiovascular Class 2 870.1250 2011-11-09
FRO Dressing, Wound, Drug Unknown Class U N/A 2008-01-10
PPA Bladder Irrigation Kit Gastroenterology, Urology Class 2 876.5130 2018-03-28
PRV Gastro-Urology Biopsy Kit Gastroenterology, Urology Class 2 876.1075 2018-06-05
PSD Laparoscopic Gastrostomy Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
KJG Tube, Tissue Culture Pathology Class 1 864.3010 2011-12-05
OFB Catheter Guide Wire Kit Cardiovascular Class 2 870.1330 2011-11-09
MYK Kit, Cord Blood Collection Unknown Class N N/A 2013-02-01
OJJ Burn Kit Without Drug General, Plastic Surgery Class 1 878.4022 2011-11-11
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 1999-10-14
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2007-04-20
OFY Dental Implant Surgical Tray Dental Class 1 872.3980 2011-11-09
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2021-05-14
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 1999-08-04
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2013-05-13
QGA Penile Implant Surgical Accessories Gastroenterology, Urology Class 1 876.3500 2020-03-18
NYC Dental Prophylaxis Kit Dental Class 1 872.4565 2011-11-09
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2007-04-20
OGW Tracheostomy Kit Anesthesiology Class 2 868.5800 2011-11-09
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2009-07-07
PIN Kidney Perfusion Kit Gastroenterology, Urology Class 2 876.5880 2018-03-15
JEB Table, Surgical With Orthopedic Accessories, Manual General, Plastic Surgery Class 1 878.4950 2012-05-22
PXM Vomitus Clean-Up Kit General Hospital Class 1 880.6890 2018-07-02
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-10-18
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2007-04-20
OGV Tracheostomy Cleaning Tray Anesthesiology Class 2 868.5800 2011-11-09
EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile Gastroenterology, Urology Class 1 876.5250 2011-07-11
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-02-01
PXZ Laparascopic Sphincterotomy Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
NWU Endoscope Introducer Kit Gastroenterology, Urology Class 2 876.1500 2011-11-10
PXY Irrigation Kit (Wounds) General, Plastic Surgery Class 1 878.4014 2018-07-02
HXD Clamp General, Plastic Surgery Class 1 878.4800 2007-04-26
OIP Radiology-Diagnostic Kit Radiology Class 2 892.1680 2011-06-27
MAC Decontamination Kit General, Plastic Surgery Class 1 878.4014 2011-11-11
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2013-01-24
PXU Fluid Drainage Tray General, Plastic Surgery Class 1 878.4200 2018-07-02
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2001-06-15
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2007-04-26
PXK Vascular Access Port Kit General Hospital Class 2 880.5965 2018-07-02
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2009-05-27
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2007-04-20
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2019-04-04
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2019-04-04
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2019-04-04
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2019-04-04
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2019-04-04
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2019-04-04
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2019-04-04
PVY Vasovasostomy Set Gastroenterology, Urology Class 1 876.4730 2018-06-06
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2026-06-12
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2015-05-14
OFS Tracheal Suction Set Anesthesiology Class 1 868.6810 2011-11-09
NXA Tracheotomy Care Kit Anesthesiology Class 2 868.5800 2011-09-08
OGG Humidifier Nebulizer Kit Anesthesiology Class 2 868.5450 2011-11-09
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2007-04-26
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2010-09-20
PWL Oral Surgery Tray Dental Class 1 872.4565 2018-06-06
PYG Suction Catheter Kit General, Plastic Surgery Class 1 878.4200 2018-07-02
OKG Body Fluid Clean Up Kit General, Plastic Surgery Class 2 878.4040 2011-11-11
EFN Cotton, Roll Dental Class 1 872.6050 2009-06-25
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2007-04-20
OFQ Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
NYG Lapping Tool Kit Dental Class 1 872.4565 2011-11-09
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2010-04-12
OGU Pierced Ear/Entry Cleaning Tray Ear, Nose, Throat Class 1 874.4420 2011-11-09
MFY Endothelial Cell Harvesting Kit Cardiovascular Class 2 870.4075 2011-11-09
PXQ Burn Dressing Tray General, Plastic Surgery Class 1 878.4022 2018-07-02
JYA Scissors, Wire Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2007-04-26
OFH Digital Angiography Tray Cardiovascular Class 2 870.1650 2011-11-09
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2016-05-11

Official Correspondent

No official correspondent registered.

US Agent Details

Stacey Henning Email: stacey.henning@cardinalhealth.com Phone: (312) 2702081

Related Public Records

Same Entity

Cardinal Health 200, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004839227 Cardinal Health Malta 212 Ltd Marsa, MT
3015541720 Cardinal Health Germany Manufacturing GmbH Halberstadt Saxony-Anhalt, DE
1033903 Cardinal Health Greenwood, SC, US
9611018 Cardinal Health Ireland Manufacturing Limited TULLAMORE Offaly, IE
8040459 Kendall-Gammatron Limited SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30
K943349 Quinton, Inc. MAHURKAR DUAL LUMEN CATHETER 1995-03-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616088. Last updated year: 2026. Please use registration number 9616088 when referencing this establishment in official correspondence.
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