| Primary Device ID | 00885556840306 |
| NIH Device Record Key | 5472a385-ec38-43fa-969f-13fde7deb81d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Total Wrist Fusion System |
| Version Model Number | 303500 |
| Catalog Number | 303500 |
| 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 | |
| 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 | 00885556840306 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
[00885556840306]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-10 |
| Device Publish Date | 2023-02-02 |
| 00885556840368 | INSTRUMENT CASE COMPLETE - EMEA |
| 00885556840306 | INSTRUMENT CASE COMPLETE - US |
| 00885556840269 | PLATE BENDER - 3.5MM HOLE |
| 00885556840252 | PLATE BENDER - 2.7MM HOLE |
| 00885556840245 | 2.0MM SELF-RETAINING HEX DRIVER |
| 00885556840238 | 2.5MM SELF-RETAINING HEX DRIVER |
| 00885556840221 | SELF-RETAINING TORX DRIVER |
| 00885556840214 | DEPTH GAUGE |
| 00885556840184 | DOUBLE-ENDED GUIDE FOR 2.5MM CORTICAL DRILL BIT |
| 00885556840177 | DOUBLE-ENDED GUIDE FOR 2.0MM CORTICAL DRILL BIT |
| 00885556840344 | INSTRUMENT CASE LID (US/EMEA) |
| 00885556840320 | INSTRUMENT CASE TOP LEVEL (US/EMEA) |
| 00885556840290 | SHORT BEND PLATE TRIAL (EMEA SETS ONLY) |
| 00885556840283 | STANDARD BEND PLATE TRIAL (EMEA SETS ONLY) |
| 00885556840276 | STRAIGHT PLATE TRIAL (EMEA SETS ONLY) |
| 00885556840542 | 3.5MM CORTICAL SCREW 28MM LONG |
| 00885556840535 | 3.5MM CORTICAL SCREW 26MM LONG |
| 00885556840528 | 3.5MM CORTICAL SCREW 24MM LONG |
| 00885556840511 | 3.5MM CORTICAL SCREW 22MM LONG |
| 00885556840504 | 3.5MM CORTICAL SCREW 20MM LONG |
| 00885556840498 | 3.5MM CORTICAL SCREW 18MM LONG |
| 00885556840481 | 3.5MM CORTICAL SCREW 16MM LONG |
| 00885556840474 | 3.5MM CORTICAL SCREW 14MM LONG |
| 00885556840467 | 3.5MM CORTICAL SCREW 12MM LONG |
| 00885556840450 | 2.7MM CORTICAL SCREW 24MM LONG |
| 00885556840443 | 2.7MM CORTICAL SCREW 22MM LONG |
| 00885556840436 | 2.7MM CORTICAL SCREW 20MM LONG |
| 00885556840429 | 2.7MM CORTICAL SCREW 18MM LONG |
| 00885556840412 | 2.7MM CORTICAL SCREW 16MM LONG |
| 00885556840405 | 2.7MM CORTICAL SCREW 14MM LONG |
| 00885556840399 | 2.7MM CORTICAL SCREW 12MM LONG |
| 00885556840382 | 2.7MM CORTICAL SCREW 10MM LONG |
| 00885556840375 | INSTRUMENT CASE BASE (EMEA) |
| 00885556840351 | WRIST FUSION SCREW CADDY LID |
| 00885556840337 | INSTRUMENT CASE IMPLANT CADDY (US) |
| 00885556840313 | INSTRUMENT CASE BASE (US) |
| 00885556840207 | THREADED SURFIX DRILL GUIDE FOR 2.7MM DRILL BIT |
| 00885556840191 | THREADED SURFIX DRILL GUIDE FOR 2.0MM DRILL BIT |
| 00885556840160 | 2.7MM DRILL BIT |
| 00885556840153 | 2.5MM DRILL BIT |
| 00885556840146 | 2.0MM DRILL BIT |
| 00885556840139 | 3.5MM CORTICAL SCREW 28MM LONG |
| 00885556840122 | 3.5MM CORTICAL SCREW 26MM LONG |
| 00885556840115 | 3.5MM CORTICAL SCREW 24MM LONG |
| 00885556840108 | 3.5MM CORTICAL SCREW 22MM LONG |
| 00885556840092 | 3.5MM CORTICAL SCREW 20MM LONG |
| 00885556840085 | 3.5MM CORTICAL SCREW 18MM LONG |
| 00885556840078 | 3.5MM CORTICAL SCREW 16MM LONG |
| 00885556840061 | 3.5MM CORTICAL SCREW 14MM LONG |
| 00885556840054 | 3.5MM CORTICAL SCREW 12MM LONG |