| Primary Device ID | 00885556826324 |
| NIH Device Record Key | 54023f0d-1f4b-4289-937f-6d36b1ecd491 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First Choice Modular Ulnar Head Implant |
| Version Model Number | OSG-600-01 |
| Catalog Number | OSG-600-01 |
| 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 | 00885556826324 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
Moist Heat or Steam Sterilization
[00885556826324]
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 |
| 00885556826324 | MUH OSTEOTOMY GUIDE |
| 00885556826317 | MUH RESECTION GUIDE |
| 00885556826171 | MUH STEM IMPACTOR |
| 00885556826089 | MUH REAMER SZ. 6.5 |
| 00885556826072 | MUH REAMER SZ. 5.5 |
| 00885556826065 | MUH REAMER SZ. 4.5 |
| 00885556826058 | MUH REAMER SZ. 3.5 |
| 00885556826300 | MUH STEM SZ. 6.5 S |
| 00885556826294 | MUH STEM SZ. 6.5 M |
| 00885556826287 | MUH STEM SZ. 6.5 L |
| 00885556826270 | MUH STEM SZ. 5.5 S |
| 00885556826263 | MUH STEM SZ. 5.5 M |
| 00885556826256 | MUH STEM SZ. 5.5 L |
| 00885556826249 | MUH STEM SZ. 4.5 S |
| 00885556826232 | MUH STEM SZ. 4.5 M |
| 00885556826225 | MUH STEM SZ. 4.5 L |
| 00885556826218 | MUH HEAD SZ. 19.0 |
| 00885556826201 | MUH HEAD SZ. 17.5 |
| 00885556826195 | MUH HEAD SZ. 16.0 |
| 00885556826652 | MUH STEM TRIAL SZ. 6.5 |
| 00885556826645 | MUH STEM TRIAL SZ. 5.5 |
| 00885556826638 | MUH STEM TRIAL SZ. 4.5 |
| 00885556826614 | MUH TRIAL COLLAR LONG |
| 00885556826607 | MUH HEAD TRIAL SZ. 19 |
| 00885556826591 | MUH HEAD TRIAL SZ. 17.5 |
| 00885556826584 | MUH HEAD TRIAL SZ. 16 |
| 00885556826188 | MUH BACK TABLE ASSY PAD |
| 00885556826096 | MUH INSTRUMENT CASE BASE |