| Primary Device ID | 00885556826102 |
| NIH Device Record Key | 07c9eef1-2ee6-4be7-9d29-c7e9a97933f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First Choice Partial Ulnar Head Implant |
| Version Model Number | CSA-610-01 |
| Catalog Number | CSA-610-01 |
| Company DUNS | 045483575 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556826102 [Primary] |
| OJH | Orthopedic tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
[00885556826102]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-07 |
| Device Publish Date | 2022-12-21 |
| 00885556826331 | DRUJ OSTEOTOMY GUIDE |
| 00885556826577 | FIRST CHOICE HEAD 19.0-STEM 6.5 |
| 00885556826560 | FIRST CHOICE HEAD 19.0-STEM 5.5 |
| 00885556826553 | FIRST CHOICE HEAD 19.0-STEM 4.5 |
| 00885556826546 | FIRST CHOICE HEAD 17.5-STEM 6.5 |
| 00885556826539 | FIRST CHOICE HEAD 17.5-STEM 5.5 |
| 00885556826522 | FIRST CHOICE HEAD 17.5-STEM 4.5 |
| 00885556826515 | FIRST CHOICE HEAD 16.0-STEM 6.5 |
| 00885556826508 | FIRST CHOICE HEAD 16.0-STEM 5.5 |
| 00885556826492 | FIRST CHOICE HEAD 16.0-STEM 4.5 |
| 00885556826485 | FIRST CHOICE HEAD 14.5-STEM 6.5 |
| 00885556826478 | FIRST CHOICE HEAD 14.5-STEM 5.5 |
| 00885556826461 | FIRST CHOICE HEAD 14.5-STEM 4.5 |
| 00885556826454 | DRUJ TRIAL SZ. 190-65 |
| 00885556826447 | DRUJ TRIAL SZ. 190-55 |
| 00885556826430 | DRUJ TRIAL SZ. 190-45 |
| 00885556826423 | DRUJ TRIAL SZ. 175-65 |
| 00885556826416 | DRUJ TRIAL SZ. 175-55 |
| 00885556826409 | DRUJ TRIAL SZ. 175-45 |
| 00885556826393 | DRUJ TRIAL SZ. 160-65 |
| 00885556826386 | DRUJ TRIAL SZ. 160-55 |
| 00885556826379 | DRUJ TRIAL SZ. 160-45 |
| 00885556826362 | DRUJ TRIAL SZ. 145-65 |
| 00885556826355 | DRUJ TRIAL SZ. 145-55 |
| 00885556826348 | DRUJ TRIAL SZ. 145-45 |
| 00885556826119 | FIRST CHOICE/DRUJ SYSTEM TAG |
| 00885556826102 | FIRST CHOICE INSERT |