| Primary Device ID | 00885556827512 |
| NIH Device Record Key | fd543253-b428-42c2-9919-b215e372e2bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Katalyst Bipolar Radial Head System |
| Version Model Number | 225205KMI |
| Catalog Number | 225205KMI |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556827512 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
Moist Heat or Steam Sterilization
[00885556827512]
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 |
| 00885556827536 | FIRST SPACER |
| 00885556827529 | SPACERS 2MM. WRENCH |
| 00885556827512 | KATALYST ASSEMBLY PLIERS |
| 00885556827499 | STARTER AWL |
| 00885556827451 | HEAD SIZING FIXTURE |
| 00885556827444 | CUTTING TEMPLATE |
| 00885556827437 | BROACH. 7.5MM X 20MM |
| 00885556827420 | BROACH 6.5MM X 20MM |
| 00885556827291 | SIZING WAND INSTRUMENT CASE |
| 00885556827284 | SIZING WAND CASE LID |
| 00885556834909 | HEX DRIVER. 2.5MM |
| 00885556827314 | 21MM KATALYST RADIAL HEAD |
| 00885556827307 | 18MM KATALYST RADIAL HEAD |