| Primary Device ID | 00885556740231 |
| NIH Device Record Key | a392639e-134f-442f-bc1d-e69fc1c1b829 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GII |
| Version Model Number | E0016363-8 |
| Catalog Number | E0016363-8 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556740231 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
[00885556740231]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-25 |
| 00885556741252 | GII PS HIGH FLEX INSERT 7-8 12MM |
| 00885556741245 | GII PS HIGH FLEX INSERT 7-8 11MM |
| 00885556741238 | GII PS HIGH FLEX INSERT 7-8 10MM |
| 00885556741221 | GII PS HIGH FLEX INSERT 7-8 9MM |
| 00885556741214 | GII PS HIGH FLEX INSERT 5-6 12MM |
| 00885556741207 | GII PS HIGH FLEX INSERT 5-6 11MM |
| 00885556741191 | GII PS HIGH FLEX INSERT 5-6 10MM |
| 00885556741184 | GII PS HIGH FLEX INSERT 5-6 9MM |
| 00885556741177 | GII PS HIGH FLEX INSERT 3-4 12MM |
| 00885556741160 | GII PS HIGH FLEX INSERT 3-4 11MM |
| 00885556741153 | GII PS HIGH FLEX INSERT 3-4 10MM |
| 00885556741146 | GII PS HIGH FLEX INSERT 3-4 9MM |
| 00885556741139 | GII PS HIGH FLEX INSERT 1-2 12MM |
| 00885556741122 | GII PS HIGH FLEX INSERT 1-2 11MM |
| 00885556741115 | GII PS HIGH FLEX INSERT 1-2 10MM |
| 00885556741108 | GII PS HIGH FLEX INSERT 1-2 9MM |
| 00885556740316 | GII CONST. ARTICULAR INSERT 7-8 11MM |
| 00885556740309 | GII CONST. ARTICULAR INSERT 7-8 9MM |
| 00885556740293 | GII CONST. ARTICULAR INSERT 5-6 11MM |
| 00885556740286 | GII CONST. ARTICULAR INSERT 5-6 9MM |
| 00885556740279 | GII CONST. ARTICULAR INSERT 3-4 11MM |
| 00885556740262 | GII CONST. ARTICULAR INSERT 3-4 9MM |
| 00885556740255 | GII CONST. ARTICULAR INSERT 1-2 11MM |
| 00885556740248 | GII CONST. ARTICULAR INSERT 1-2 9MM |
| 00885556740231 | GII DISH ARTICULAR INSERT 7-8 11MM |
| 00885556740224 | GII DISH ARTICULAR INSERT 7-8 9MM |
| 00885556740217 | GII DISH ARTICULAR INSERT 5-6 11MM |
| 00885556740200 | GII DISH ARTICULAR INSERT 5-6 9MM |
| 00885556740194 | GII DISH ARTICULAR INSERT 3-4 11MM |
| 00885556740187 | GII DISH ARTICULAR INSERT 3-4 9MM |
| 00885556740170 | GII DISH ARTICULAR INSERT 1-2 11MM |
| 00885556740163 | GII DISH ARTICULAR INSERT 1-2 9MM |
| 00885556740156 | GII CR DEEP FLEX INSERT TRIAL 7-8 12MM |
| 00885556740149 | GII CR DEEP FLEX INSERT TRIAL 7-8 11MM |
| 00885556740132 | GII CR DEEP FLEX INSERT TRIAL 7-8 10MM |
| 00885556740125 | GII CR DEEP FLEX INSERT TRIAL 7-8 9MM |
| 00885556740118 | GII CR DEEP FLEX INSERT TRIAL 5-6 12MM |
| 00885556740101 | GII CR DEEP FLEX INSERT TRIAL 5-6 11MM |
| 00885556740095 | GII CR DEEP FLEX INSERT TRIAL 5-6 10MM |
| 00885556740088 | GII CR DEEP FLEX INSERT TRIAL 5-6 9MM |
| 00885556740071 | GII CR DEEP FLEX INSERT TRIAL 3-4 12MM |
| 00885556740064 | GII CR DEEP FLEX INSERT TRIAL 3-4 11MM |
| 00885556740057 | GII CR DEEP FLEX INSERT TRIAL 3-4 10MM |
| 00885556740040 | GII CR DEEP FLEX INSERT TRIAL 3-4 9MM |
| 00885556740033 | GII CR DEEP FLEX INSERT TRIAL 1-2 12MM |
| 00885556740026 | GII CR DEEP FLEX INSERT TRIAL 1-2 11MM |
| 00885556740019 | GII CR DEEP FLEX INSERT TRIAL 1-2 10MM |
| 00885556740002 | GII CR DEEP FLEX INSERT TRIAL 1-2 9MM |
| 00885556739990 | PITCHFORK HANDLE |
| 00885556739983 | GII CR FEMORAL IMPACTOR |