Primary Device ID | 00885556827383 |
NIH Device Record Key | fa2afaca-8c16-4ed6-8210-72096a99df2c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Katalyst Biopolar Radial Head System |
Version Model Number | 224318 |
Catalog Number | 224318 |
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 | 00885556827383 [Primary] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
Moist Heat or Steam Sterilization
[00885556827383]
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 |