Cofield 71249508

GUDID 03596010472793

COFIELD2 ONE PIECE HUM TRIAL 8MM X 145MM

Smith & Nephew, Inc.

Humeral stem prosthesis trial

• Primary Device ID: 03596010472793
• NIH Device Record Key: 71d45eaa-9340-47a0-bca5-04e92578f7d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cofield
• Version Model Number: 71249508
• Catalog Number: 71249508
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010472793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121714

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

[03596010472793]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-11
• Device Publish Date: 2015-08-29

On-Brand Devices [Cofield]

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