Primary Device ID | 00885556865378 |
NIH Device Record Key | e11c6061-40c0-4582-8fa5-61ff58cddd75 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Universal2 Total Wrist Implant System |
Version Model Number | 268136 |
Catalog Number | 268136 |
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 | true |
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 | 00885556865378 [Primary] |
HTW | BIT, DRILL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
[00885556865378]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-02-20 |
Device Publish Date | 2023-02-10 |
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 |