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

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

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 Nonrepro-cessed 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.

Updated September 12, 2006

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