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U.S. Department of Health and Human Services

Medical Devices

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List 2 - Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Now Require the Submission of Validation

(From September 29, 2005, Federal Register Notice)

21 CFR No. Classification Name Product Code for Nonreprocessed Device Product Code for Reprocessed Device Product Code Name for Reprocessed Device
Unclassified Oocyte Aspiration Needles MHK NMO Oocyte Aspiration Needles
Unclassified Percutaneous Transluminal Angioplasty Catheter LIT NMM Transluminal Peripheral Angioplasty Catheter
Unclassified Ultrasonic Surgical Instrument LFL NLQ Ultrasonic Scalpel
868.5150 Anesthesia Conduction Needle BSP NNH Anesthetic Conduction Needle (with/without Introducer)
868.5150 Anesthesia Conduction Needle MIA NMR Short Term Spinal Needle
868.5730 Tracheal Tube BTR NMA Tracheal Tube (with/without connector)
868.5905 Noncontinous Ventilator (IPPB) BZD NMC Noncontinuous Ventilator (Respirator Mask)
870.1200 Diagnostic Intravascular Catheter DQO NLI Angiography Catheter
870.1220 Electrode Recording Catheter DRF NLH Electrode Recording Catheter
870.1220 Electrode Recording Catheter MTD NLG Intracardiac Mapping Catheter
870.1230 Fiberoptic Oximeter Catheter DQE NMB Fiberoptic Oximeter Catheter
870.1280 Steerable Catheter DRA NKS Steerable Catheter
870.1290 Steerable Catheter Control System DXX NKR Steerable Catheter Control System
870.1330 Catheter Guide Wire DQX NKQ Catheter Guide Wire
870.1390 Trocar DRC NMK Cardiovascular Trocar
870.1650 Angiographic Injector and Syringe DXT NKT Angiographic Injector and Syringe
870.1670 Syringe Actuator for Injector DQF NKW Injector for Actuator Syringe
870.2700 Oximeter MUD NMD Tissue Saturation Oximeter
870.2700 Oximeter DQA NLF Oximeter
870.3535 Intra-Aortic Balloon and Control System DSP NKO Intra-Aortic Balloon and Control System
870.4450 Vascular Clamp DXC NMF Vascular Clamp
870.4885 External Vein Stripper DWQ NLJ External Vein Stripper
872.5470 Orthodontic Plastic Bracket DYW NLC Orthodontic Plastic Bracket
874.4680 Bronchoscope (Flexible or Rigid) and Accessories BWH NLE Bronchoscope (Nonrigid Biopsy Forceps)
876.1075 Gastro-Urology Biopsy Instrument FCG NMX G-U Biopsy Needle and Needle Set
876.1075 Gastro-Urology Biopsy Instrument KNW NLS Biopsy Instrument
876.1500 Endoscope and Accessories FBK, FHP NMY Endoscopic Needle
876.1500 Endoscope and Accessories MPA NKZ Endoilluminator
876.1500 Endoscope and Accessories GCJ NLM General and Plastic Surgery Laparoscope
876.1500 Endoscope and Accessories FHO NLX Spring-Loaded Pneumoperitoneum Needle
876.4300 Endoscopic Electrosurgical Unit and Accessories FAS NLW Active Urological Electrosurgical Electrode
876.4300 Endoscopic Electrosurgical Unit and Accessories FEH NLV Flexible Suction Coagulator Electrode
876.4300 Endoscopic Electrosurgical Unit and Accessories KGE NLU Electric Biopsy Forceps
876.4300 Endoscopic Electrosurgical Unit and Accessories FDI NLT Flexible Snare
876.4300 Endoscopic Electrosurgical Unit and Accessories KNS NLR Endoscopic (with or without accessories) Electrosurgical Unit
876.5010 Biliary Catheter and Accessories FGE NML Biliary Catheter
876.5540 Blood Access Device and Accessories LBW NNF Single Needle Dialysis Set (co-axial flow)
876.5540 Blood Acces Device and Accessories FIE NNE Fistula Needle
876.5820 Hemodialysis Systems and Accessories FIF NNG Single Needle Dialysis Set with Uni-Directional Pump
878.4300 Implantable Clip FZP NMJ Implantable Clip
878.4400 Electrosurgical Cutting and Coagulation Device and Accessories GEI NUJ Endoscopic and Laparoscopic Electrosurgical Accessories
878.4750 Implantable Staple GDW NLL Implantable Staple
880.5570 Hypodermic Single Lumen Needle FMI NKK Hypodermic Single Lumen Needle
880.5860 Piston Syringe FMF NKN Piston Syringe
882.4300 Manual Cranial Drills, Burrs, Trephines and Accessories HBG NLO (Manual) Drills, Burrs, Trephines, and Accessories
882.4305 Powered Compound Cranial Drills, Burrs, Trephines HBF NLP (Powered, Compound) Drills, Burrs, Trephines and Accessories
882.4310 Powered Simple Cranial Drills, Burrs, Trephines HBE NLN (Simple, Powered) Drills, Burrs, Trephines and Accessories
884.1720 Gynecologic Laparoscope and Accessories HET NMH Gynecologic Laparoscope (and Accessories)
884.6100 Assisted Reproduction Needle MQE NNB Assisted Reproduction Needle
886.4370 Keratome HMY, HNO NKY Keratome Blade
886.4670 Phacofragmentation System HQC NKX Phacoemulsification Needle
892.5730 Radionuclide Brachytherapy Source IWF NMP Isotope Needle

Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in "Draft Guidance for Hemodialyzer Reuse Labeling" October 6, 1995. An archived copy may be obtained from CDRH's Division of Small Manufacturers, International, and Consumer Assistance, please contact dsmica@cdrh.fda.gov.