| Primary Device ID | 00885556738320 |
| NIH Device Record Key | 97723110-0a8b-4e98-851f-e4873e753f08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JII |
| Version Model Number | E0016338-12 |
| Catalog Number | E0016338-12 |
| 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)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 | 00885556738320 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
[00885556738320]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2019-03-11 |
| 00885556741597 | IM TIBIAL STYLUS ASSEMBLY |
| 00885556740422 | IM ROD SHORT |
| 00885556740415 | IM ROD LONG |
| 00885556740408 | SEVEN DEGREE VALGUS COLLET |
| 00885556740392 | SIX DEGREE VALGUS COLLET |
| 00885556740385 | FIVE DEGREE VALGUS COLLET |
| 00885556740378 | FOUR DEGREE VALGUS COLLET |
| 00885556740361 | ADJUSTABLE VALGUS GUIDE |
| 00885556740354 | FIXED VALGUS GUIDE |
| 00885556740347 | FIXED VALGUS BRIDGE |
| 00885556740330 | DISTAL FEMORAL CUTTING BLOCK |
| 00885556738566 | JII BCS TRIAL INSERT 7-8 12MM R |
| 00885556738559 | JII BCS TRIAL INSERT 7-8 11MM R |
| 00885556738542 | JII BCS TRIAL INSERT 7-8 10MM R |
| 00885556738535 | JII BCS TRIAL INSERT 7-8 9MM R |
| 00885556738528 | JII BCS TRIAL INSERT 5-6 12MM R |
| 00885556738511 | JII BCS TRIAL INSERT 5-6 11MM R |
| 00885556738504 | JII BCS TRIAL INSERT 5-6 10MM R |
| 00885556738498 | JII BCS TRIAL INSERT 5-6 9MM R |
| 00885556738481 | JII BCS TRIAL INSERT 3-4 12MM R |
| 00885556738474 | JII BCS TRIAL INSERT 3-4 11MM R |
| 00885556738467 | JII BCS TRIAL INSERT 3-4 10MM R |
| 00885556738450 | JII BCS TRIAL INSERT 3-4 9MM R |
| 00885556738443 | JII BCS TRIAL INSERT 1-2 12MM R |
| 00885556738436 | JII BCS TRIAL INSERT 1-2 11MM R |
| 00885556738429 | JII BCS TRIAL INSERT 1-2 10MM R |
| 00885556738412 | JII BCS TRIAL INSERT SZ 1-2 9MM R |
| 00885556738405 | PITCHFORK HANDLE FOR TRIAL INSERTS |
| 00885556738399 | JII BCS TRIAL INSERT 7-8 12MM L |
| 00885556738382 | JII BCS TRIAL INSERT 7-8 11MM L |
| 00885556738368 | JII BCS TRIAL INSERT 7-8 10MM L |
| 00885556738344 | JII BCS TRIAL INSERT 7-8 9MM L |
| 00885556738320 | JII BCS TRIAL INSERT 5-6 12MM L |
| 00885556738306 | JII BCS TRIAL INSERT 5-6 11MM L |
| 00885556738290 | JII BCS TRIAL INSERT 5-6 10MM L |
| 00885556738276 | JII BCS TRIAL INSERT 5-6 9MM L |
| 00885556738269 | JII BCS TRIAL INSERT 3-4 12MM L |
| 00885556738245 | JII BCS TRIAL INSERT 3-4 11MM L |
| 00885556738221 | JII BCS TRIAL INSERT 3-4 10MM L |
| 00885556738214 | JII BCS TRIAL INSERT 3-4 9MM L |
| 00885556738191 | JII BCS TRIAL INSERT SZ 1-2 12MM L |
| 00885556738184 | JII BCS TRIAL INSERT SZ 1-2 11MM L |
| 00885556738177 | JII BCS TRIAL INSERT SZ 1-2 10MM L |
| 00885556738160 | JII BCS TRIAL INSERT SZ 1-2 9MM L |
| 00885556738092 | JII DD TRIAL INSERT 7-8 12MM R |
| 00885556738085 | JII DD TRIAL INSERT 7-8 11MM R |
| 00885556738078 | JII DD TRIAL INSERT 7-8 10MM R |
| 00885556738061 | JII DD TRIAL INSERT 7-8 9MM R |
| 00885556738054 | JII DD TRIAL INSERT 5-6 12MM R |
| 00885556738047 | JII DD TRIAL INSERT 5-6 11MM R |