| Primary Device ID | 00885556827277 | 
| NIH Device Record Key | 46e03f85-1a62-49bf-99c2-26190f685b8f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Katalyst Biopolar Radial Head System | 
| Version Model Number | 221001 | 
| Catalog Number | 221001 | 
| 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 | 00885556827277 [Primary] | 
| FSM | TRAY, SURGICAL, INSTRUMENT | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
[00885556827277]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2023-05-03 | 
| Device Publish Date | 2023-01-19 | 
| 00885556827505 | KATALYST NYLON DEMO HOLDER | 
| 00885556827406 | TRIAL - RADIAL HEAD: 24MM | 
| 00885556827390 | TRIAL - RADIAL HEAD: 21MM | 
| 00885556827383 | TRIAL - RADIAL HEAD: 18MM | 
| 00885556827376 | TRIAL. STEM / SHAFT - 7.5MM | 
| 00885556827369 | TRIAL. STEM / SHAFT - 6.5MM | 
| 00885556827277 | KATALYST STERILIZATION TRAY | 
| 00885556827352 | REPLACEMENT SET SCREW | 
| 00885556827345 | 7.5MM KATALYST STEM | 
| 00885556827338 | 6.5MM KATALYST STEM | 
| 00885556827321 | 24MM KATALYST RADIAL HEAD | 
| 00885556827482 | 24MM RADIAL HEAD SIZING WAND | 
| 00885556827475 | 21MM RADIAL HEAD SIZING WAND | 
| 00885556827468 | 18MM RADIAL HEAD SIZING WAND |