| Primary Device ID | 00885556857489 |
| NIH Device Record Key | 03905e73-7357-42d2-b95a-6f6fa8c74873 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Modular Radial Head (MRH) System |
| Version Model Number | OSG-350-01 |
| Catalog Number | OSG-350-01 |
| 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 | 00885556857489 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
Moist Heat or Steam Sterilization
[00885556857489]
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 |
| 00885556866054 | MRH PLANAR |
| 00885556857489 | OSTEOTOMY CUT GUIDE. MRH |
| 00885556857472 | MRH REAMER SZ. 03 |
| 00885556857465 | MRH REAMER SZ. 02 |
| 00885556857458 | MRH REAMER SZ. 01 |
| 00885556857335 | IMPACTOR. STEM. MRH |
| 00885556857441 | MODULAR RADIAL HEAD SZ. 24S WW |
| 00885556857434 | MODULAR RADIAL HEAD SZ. 24L WW |
| 00885556857427 | MODULAR RADIAL HEAD SZ. 22S WW |
| 00885556857410 | MODULAR RADIAL HEAD SZ. 22L WW |
| 00885556857403 | MODULAR RADIAL HEAD SZ. 20S WW |
| 00885556857397 | MODULAR RADIAL HEAD SZ. 20L WW |
| 00885556857380 | MODULAR RADIAL HEAD STEM SZ. 04 WW |
| 00885556857373 | MODULAR RADIAL HEAD STEM SZ. 03 WW |
| 00885556857366 | MODULAR RADIAL HEAD STEM SZ. 02 WW |
| 00885556857359 | MODULAR RADIAL HEAD STEM SZ. 01 WW |
| 00885556857601 | MRH HEAD TRIAL SZ. 24S |
| 00885556857595 | MRH HEAD TRIAL SZ. 24L |
| 00885556857588 | MRH HEAD TRIAL SZ. 22S |
| 00885556857571 | MRH HEAD TRIAL SZ. 22L |
| 00885556857564 | MRH HEAD TRIAL SZ. 20S |
| 00885556857557 | MRH HEAD TRIAL SZ. 20L |
| 00885556857540 | MRH TRIAL. TI. SZ. 24S |
| 00885556857533 | MRH TRIAL. TI. SZ. 24L |
| 00885556857526 | MRH TRIAL. TI. SZ. 22S |
| 00885556857519 | MRH TRIAL. TI. SZ. 22L |
| 00885556857502 | MRH TRIAL. TI. SZ. 20S |
| 00885556857496 | MRH TRIAL. TI. SZ. 20L |
| 00885556857342 | BACK TABLE ASSEMBLY PAD. MRH |
| 00885556857311 | STEM HOLDER. MRH |
| 00885556857304 | GENERIC METAL INSTRMT CASE BASE #85-0702 |
| 00885556857298 | GENERIC METAL INSTRMNT CASE LID #85-0701 |
| 00885556857281 | INSTRUMENT CASE. BASE. MRH. #05-3572 |
| 00885556857267 | BROACH. MRH. SZ. 04 |
| 00885556857250 | RADIAL HEAD BROACH SIZE 24 |
| 00885556857243 | RADIAL HEAD BROACH SIZE 22 |
| 00885556857236 | RADIAL HEAD BROACH SIZE 20 |