| Primary Device ID | 03596010460813 |
| NIH Device Record Key | a51c5f8e-c169-4eda-b290-4cad5c8e4b20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COFIELD |
| Version Model Number | 71249853 |
| Catalog Number | 71249853 |
| 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 |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03596010460813 [Primary] |
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
[03596010460813]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2015-08-29 |
| 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 |