| Primary Device ID | 00885556855201 |
| NIH Device Record Key | 5c24ce05-6d75-4e83-aa55-667b3e3b0889 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Freedom Wrist Arthroplasty System |
| Version Model Number | 348103 |
| Catalog Number | 348103 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556855201 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
Moist Heat or Steam Sterilization
[00885556855201]
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 |
| 00885556855539 | RADIAL DRILL GUIDE. RIGHT |
| 00885556855522 | RADIAL DRILL GUIDE. LEFT |
| 00885556855515 | RADIAL TRIAL REMOVER |
| 00885556855386 | RADIAL RESECTION GUIDE SIZE 3 |
| 00885556855379 | RADIAL RESECTION GUIDE SIZE 2 |
| 00885556855362 | RADIAL RESECTION GUIDE SIZE 1 |
| 00885556855355 | RADIAL FEELER |
| 00885556855348 | RADIAL IM GUIDE ROD |
| 00885556855331 | RADIAL TEMPLATE SIZE 3 |
| 00885556855324 | RADIAL TEMPLATE SIZE 2 |
| 00885556855317 | RADIAL TEMPLATE SIZE 1 |
| 00885556855232 | RADIAL TRIAL. SIZE 3. RIGHT |
| 00885556855225 | RADIAL TRIAL. SIZE 3. LEFT |
| 00885556855218 | RADIAL TRIAL. SIZE 2. RIGHT |
| 00885556855201 | RADIAL TRIAL. SIZE 2. LEFT |
| 00885556855195 | RADIAL TRIAL. SIZE 1. RIGHT |
| 00885556855171 | 2.5MM HEX DRIVER |
| 00885556855164 | T15 STAR DRIVER |
| 00885556855126 | K-WIRE DEPTH GAUGE |
| 00885556855102 | TISSUE PROTECTIVE SLEEVE |
| 00885556855096 | CARPAL POLY IMPACTOR |
| 00885556855089 | CARPAL PLATE IMPACTOR |
| 00885556855072 | CARPAL CEMENT REAMER |
| 00885556855065 | CARPAL REAMER SIZE 3 |
| 00885556855058 | CARPAL REAMER SIZE 2 |
| 00885556855041 | CARPAL REAMER SIZE 1 |
| 00885556855027 | CARPAL RESECTION GUIDE |
| 00885556854990 | MODULAR DRILL GUIDE |
| 00885556854983 | CARPAL SIZER |
| 00885556855140 | 3.5MM CANNULATED DRILL BIT |
| 00885556855652 | INSTRUMENT CASE INSERT |
| 00885556855546 | ANTI-ROTATION PIN |
| 00885556855119 | K-WIRE 150 MM. 1.4 MM DIAMETER |
| 00885556855034 | HAMATE FEELER |
| 00885556856178 | 4.5MM SCREW AND LOCKING CAP 45MM LENGTH |
| 00885556856161 | 4.5MM SCREW AND LOCKING CAP 40MM LENGTH |
| 00885556856154 | 4.5MM SCREW AND LOCKING CAP 35MM LENGTH |
| 00885556856147 | 4.5MM SCREW AND LOCKING CAP 30MM LENGTH |
| 00885556856130 | 4.5MM SCREW AND LOCKING CAP 25MM LENGTH |
| 00885556856123 | 4.5MM SCREW AND LOCKING CAP 20MM LENGTH |
| 00885556856116 | 4.5MM SCREW AND LOCKING CAP 17.5MM LENGTH |
| 00885556856109 | 4.5MM SCREW AND LOCKING CAP 15MM LENGTH |
| 00885556856093 | CARPAL POLY. SIZE 3. +4 MM |
| 00885556856086 | CARPAL POLY. SIZE 3. +2 MM |
| 00885556856079 | CARPAL POLY. SIZE 3. STANDARD |
| 00885556856062 | CARPAL POLY. SIZE 2. +4 MM |
| 00885556856055 | CARPAL POLY. SIZE 2. +2 MM |
| 00885556856048 | CARPAL POLY. SIZE 2. STANDARD |
| 00885556856031 | CARPAL POLY. SIZE 1. +4 MM |
| 00885556856024 | CARPAL POLY. SIZE 1. +2 MM |