| Primary Device ID | 00885556865484 |
| NIH Device Record Key | 31a2fefb-989d-45a9-9088-b858036b3356 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal2 Total Wrist Implant System |
| Version Model Number | 268640 |
| Catalog Number | 268640 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556865484 [Primary] |
| HWA | IMPACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
[00885556865484]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
| 00885556865842 | BROACH. LARGE RIGHT |
| 00885556865835 | BROACH. LARGE LEFT |
| 00885556865828 | BROACH. MEDIUM RIGHT |
| 00885556865811 | BROACH. MEDIUM LEFT |
| 00885556865804 | BROACH. SMALL RIGHT |
| 00885556865798 | BROACH. SMALL LEFT |
| 00885556865781 | BROACH. X-SMALL RIGHT |
| 00885556865774 | BROACH. X-SMALL LEFT |
| 00885556865767 | RADIAL CUTTING GUIDE-RT |
| 00885556865750 | RADIAL CUTTING GUIDE-LF |
| 00885556865538 | SHAFT. HEX DRIVER. 2.5 |
| 00885556865521 | 6MM COUNTERSINK |
| 00885556865484 | CARPAL POLY IMPACTOR |
| 00885556865477 | T-HANDLE |
| 00885556865453 | CARPAL CUTTING GUIDE |
| 00885556865408 | RADIAL GUIDE BAR |
| 00885556865354 | GUIDE PLATE. LARGE |
| 00885556865347 | GUIDE PLATE. MEDIUM |
| 00885556865330 | GUIDE PLATE. SMALL |
| 00885556865323 | GUIDE PLATE. EXTRA-SMALL |
| 00885556865385 | DRILL BIT 4.5MM CAN. |
| 00885556865378 | DRILL BIT 3.5MM CAN. |
| 00885556865361 | DRILL BIT 2.5MM X 110MM |
| 00885556865743 | TRIAL. RADIAL LARGE. RIGHT |
| 00885556865729 | TRIAL. RADIAL MEDIUM. RIGHT |
| 00885556865705 | TRIAL. RADIAL SMALL. RIGHT |
| 00885556865682 | TRIAL. RADIAL X-SMALL. RIGHT |
| 00885556865460 | BROACH HANDLE |
| 00885556865309 | K-WIRE - 1.1MM |
| 00885556865736 | TRAIL RADIAL LARGE LEFT |
| 00885556865712 | TRAIL RADIAL MEDIUM LEFT |
| 00885556865699 | TRIAL RADIAL SMALL LEFT |
| 00885556865675 | TRIAL RADIAL X SMALL |
| 00885556865668 | UNI2 SCREW. 4.5MM X 35MM STERILE |
| 00885556865651 | UNI2 SCREW. 4.5MM X 30MM STERILE |
| 00885556865644 | UNI2 SCREW. 4.5MM X 25MM STERILE |
| 00885556865637 | UNI2 SCREW. 4.5MM X 20MM STERILE |
| 00885556865620 | UNI2 SCREW. 4.5MM X 15MM STERILE |
| 00885556865613 | RADIAL IMPLANT. LARGE RIGHT |
| 00885556865606 | RADIAL IMPLANT. LARGE LEFT |
| 00885556865590 | RADIAL IMPLANT. MEDIUM. RIGHT |
| 00885556865583 | RADIAL IMPLANT. MEDIUM. LEFT |
| 00885556865576 | RADIAL IMPLANT. SMALL. RIGHT |
| 00885556865569 | RADIAL IMPLANT. SMALL. LEFT |
| 00885556865552 | RADIAL IMPLANT X-SMALL RIGHT |
| 00885556865545 | RADIAL IMPLANT X-SMALL LEFT |
| 00885556865514 | AO QUICK COUPLE DRIVER |
| 00885556865507 | POLY IMPACTOR |
| 00885556865491 | RADIAL IMPACTOR |
| 00885556865446 | CARPAL GUIDE BAR. STANDARD |