Cofield 71259316

GUDID 03596010189820

COFIELD2 HUMERAL HEAD 16MMX38MM

Smith & Nephew, Inc.

Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis
Primary Device ID03596010189820
NIH Device Record Key6944a4cd-a4eb-4bd7-818c-2d877da2026b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCofield
Version Model Number71259316
Catalog Number71259316
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010189820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-29

On-Brand Devices [Cofield]

00885556154359MODIFIED C2 GLEN KEEL CUTTER F/USE W/ANGLE DRIVER
00885556154342MODIFIED C2 GLEN REAMER SM F/USE W/ANGLE DRIVER
00885556154335MODIFIED C2 GLEN REAMER MED F/USE W/ANGLE DRIVER
00885556154328MODIFIED C2 GLEN REAMER LG F/USE W/ANGLE DRIVER
00885556048474COFIELD II PRIMARY HUM HEAD 21MM X 48MM
00885556048283COFIELD II PRIMARY HUM HEAD 19MM X 46MM
00885556048184COFIELD II ECCENTRIC HUM HEAD 25.5MM X 50MM
00885556047941COFIELD II ECCENTRIC HUM HEAD 23.5MM X 48MM
00885556047927COFIELD II PRIMARY HUM HEAD 17MM X 44MM
00885556047729COFIELD II ECCENTRIC HUM HEAD 21.5MM X 46MM
00885556019542COFIELD SHOULDER GLENOID INSERT SMALL
00885556019030COFIELD 2 HUMERAL STEM 8X245MM
03596010189325HUMERAL HEAD REMOVAL TOOL
03596010189301COFIELD2 HUMERAL STEM IMPACTOR/EXTRACTOR
03596010000866HUMERAL STEM IMPACTOR/EXTRACTOR
03596010443762COFIELD SHOULDER GLENOID INSERT STANDARD/POST AUG
03596010480330GLENOID PEG RASP
03596010472281COFIELD2 PEGED +2MM ALL POLY GLENOID LARGE
03596010472274COFIELD2 PEGGED +2MM ALL POLY GLENOID MEDIUM
03596010472267COFIELD2 PEGGED +2MM ALL POLY GLENOID SMALL
03596010472168COFIELD2 PEGGED ALL POLY GLENOID LARGE
03596010472151COFIELD2 PEGGED ALL POLY GLENOID MEDIUM
03596010472144COFIELD2 PEGGED ALL POLY GLENOID SMALL
03596010189967COFIELD2 LIPPED ALL-POLY GLENOID LARGE
03596010189950COFIELD2 LIPPED ALL-POLY GLENOID MEDIUM
03596010189943COFIELD2 LIPPED ALL-POLY GLENOID SMALL
03596010189936COFIELD2 ALL-POLY GLENOID LARGE
03596010189929COFIELD2 ALL-POLY GLENOID MEDIUM
03596010189912COFIELD2 ALL-POLY GLENOID SMALL
03596010189622COFIELD GLENOID BASE INSERT 2 SCREWS SMALL
03596010037213COFIELD SHOULDER GLENOID ALIGNMENT PEG
03596010488084SHOULDER RETRACTORS TRAY
03596010483621HUMERAL COMMA GUIDE
03596010480309COFIELD2 TRIAL CADDY
03596010480224HUMERAL IM RESECTION GUIDE
03596010480194GLENOID TRAY
03596010480187COFIELD2 MODULAR HEAD TRAY
03596010480170HUMERAL PREP BOTTOM TRAY
03596010480163HUMERAL PREP TOP TRAY
03596010465733COFIELD II ECCENTRIC 5MM TRIAL HEAD 28MM X 50MM
03596010465726COFIELD II ECCENTRIC 5MM TRIAL HEAD 26MM X 48MM
03596010465719COFIELD II ECCENTRIC 4MM TRIAL HEAD 24MM X 46MM
03596010465702COFIELD II ECCENTRIC 4MM HEAD TRIAL 22MM X 44MM
03596010465696COFIELD ECCENTRIC 4MM HEAD TRIAL 20MM X 42MM
03596010465689COFIELD II ECCENTRIC 4MM HEAD TRIAL 18MM X 40MM
03596010465672COFIELD II ECCENTRIC 3MM HEAD TRIAL 16MM X 38MM
03596010465665COFIELD II ECCENTRIC TRIAL 1.5MM HEAD 14MM X 36MM
03596010465627COFIELD2 PEGGED ALL POLY GLENOID TRIAL LARGE
03596010465610COFIELD2 PEGGED ALL POILY GLENOID TRIAL MEDIUM
03596010465603COFIELD2 PEGGED ALL PLY GLENOID TRIAL SMALL
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