| Primary Device ID | 00885556892442 |
| NIH Device Record Key | 65d187a6-8c57-4253-9849-08b5c412883a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uni |
| Version Model Number | E0017965-8 |
| Catalog Number | E0017965-8 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556892442 [Primary] |
| HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
[00885556892442]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-09 |
| Device Publish Date | 2023-03-01 |
| 00885556706657 | MODIFIED FEMORAL UNI SIZERS - LL/RM |
| 00885556706640 | MODIFIED FEMORAL UNI SIZERS - LM/RL |
| 00885556699904 | COATED BABY LANE FORCEPS |
| 00885556753682 | ZUK SPACER BLOCK - 11MM |
| 00885556753675 | ZUK SPACER BLOCK - 9MM |
| 00885556887608 | TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM R |
| 00885556887592 | TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM L |
| 00885556887585 | TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM R |
| 00885556887578 | TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM L |
| 00885556887561 | TIBIAL ANCHOR PILOT CUTTER +0.5MM |
| 00885556887554 | LONG TIBIAL ANCHOR PILOT CUTTER +0.5MM |
| 00885556887547 | TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM R |
| 00885556887530 | TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM L |
| 00885556887523 | TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM R |
| 00885556887516 | TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM L |
| 00885556887509 | TIBIAL ANCHOR PILOT CUTTER +0.5MM |
| 00885556887493 | LONG TIBIAL ANCHOR PILOT CUTTER +0.5MM |
| 00885556887974 | TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM R |
| 00885556887967 | TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM L |
| 00885556887950 | TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM R |
| 00885556887943 | TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM L |
| 00885556887936 | TIBIAL ANCHOR PILOT CUTTER +0.5MM |
| 00885556887929 | LONG TIBIAL ANCHOR PILOT CUTTER +0.5MM |
| 00885556888063 | TIBIAL ANCHOR GUIDE 4/5/6 + 0.5MM R |
| 00885556888056 | TIBIAL ANCHOR GUIDE 4/5/6 + 0.5MM L |
| 00885556888049 | TIBIAL ANCHOR GUIDE 1/2/3 + 0.5MM R |
| 00885556888032 | TIBIAL ANCHOR GUIDE 1/2/3 + 0.5MM L |
| 00885556888025 | TIBIAL ANCHOR PILOT CUTTER |
| 00885556888018 | LONG TIBIAL ANCHOR PILOT CUTTER |
| 00885556892442 | RL TIBIA INTERACTIVE SIZER SZ 6-7 |
| 00885556892435 | RL TIBIA INTERACTIVE SIZER SZ 4-5 |
| 00885556892428 | RL TIBIA INTERACTIVE SIZER SZ 2-3 |
| 00885556892411 | RL TIBIA INTERACTIVE SIZER SZ 0-1 |
| 00885556892404 | LL TIBIA INTERACTIVE SIZER SZ 6-7 |
| 00885556892398 | LL TIBIA INTERACTIVE SIZER SZ 4-5 |
| 00885556892381 | LL TIBIA INTERACTIVE SIZER SZ 2-3 |
| 00885556892374 | LL TIBIA INTERACTIVE SIZER SZ 0-1 |
| 00885556888636 | TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM R |
| 00885556888629 | TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM L |
| 00885556888612 | TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM R |
| 00885556888605 | TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM L |
| 00885556888599 | TIBIAL ANCHOR PILOT CUTTER +0.5MM |
| 00885556888582 | LONG TIBIAL ANCHOR PILOT CUTTER +0.5MM |
| 00885556918913 | RL JII UK TIB TRIAL SZ 7 W/ POST |
| 00885556918906 | RL JII UK TIB TRIAL SZ 6 W/ POST |
| 00885556918890 | RL JII UK TIB TRIAL SZ 5 W/ POST |
| 00885556918883 | RL JII UK TIB TRIAL SZ 4 W/ POST |
| 00885556918876 | RL JII UK TIB TRIAL SZ 3 W/ POST |
| 00885556918869 | RL JII UK TIB TRIAL SZ 2 W/ POST |
| 00885556918852 | RL JII UK TIB TRIAL SZ 1 W/ POST |