| Primary Device ID | 03700386974465 |
| NIH Device Record Key | 1b565cbe-300f-4e11-ab31-52a23060b59a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tornier Perform |
| Version Model Number | MWE422 |
| Catalog Number | MWE422 |
| Company DUNS | 260324876 |
| Company Name | TORNIER |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com | |
| Phone | +330476613500 |
| order@tornier.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700386974465 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
[03700386974465]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-16 |
| Device Publish Date | 2022-08-08 |
| 03700386995590 | THREADED ROD |
| 03700386991196 | Quick Release Handle |
| 03700386991189 | T-Handle |
| 03700386974625 | KEELED GLENOID TRIAL |
| 03700386974618 | KEELED GLENOID TRIAL |
| 03700386974601 | KEELED GLENOID TRIAL |
| 03700386974595 | KEELED GLENOID TRIAL |
| 03700386974588 | KEELED GLENOID TRIAL |
| 03700386974571 | KEELED GLENOID TRIAL |
| 03700386974564 | KEELED GLENOID TRIAL |
| 03700386974557 | KEELED GLENOID TRIAL |
| 03700386974540 | KEELED GLENOID TRIAL |
| 03700386974533 | KEELED GLENOID TRIAL |
| 03700386974526 | KEELED GLENOID TRIAL |
| 03700386974519 | KEELED GLENOID TRIAL |
| 03700386974502 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974496 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974489 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974472 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974465 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974458 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974441 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974434 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974427 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974410 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974403 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974397 | CortiLoc™ PEGGED GLENOID TRIAL |
| 03700386974380 | PEGGED GLENOID TRIAL |
| 03700386974373 | PEGGED GLENOID TRIAL |
| 03700386974366 | PEGGED GLENOID TRIAL |
| 03700386974359 | PEGGED GLENOID TRIAL |
| 03700386974342 | PEGGED GLENOID TRIAL |
| 03700386974335 | PEGGED GLENOID TRIAL |
| 03700386974328 | PEGGED GLENOID TRIAL |
| 03700386974311 | PEGGED GLENOID TRIAL |
| 03700386974304 | PEGGED GLENOID TRIAL |
| 03700386974298 | PEGGED GLENOID TRIAL |
| 03700386974281 | PEGGED GLENOID TRIAL |
| 03700386974274 | PEGGED GLENOID TRIAL |
| 03700386974267 | CRESCENT REAMER |
| 03700386974250 | CRESCENT REAMER |
| 03700386974243 | CRESCENT REAMER |
| 03700386974236 | CRESCENT REAMER |
| 03700386974229 | CRESCENT REAMER |
| 03700386974212 | CRESCENT REAMER |
| 03700386974205 | CRESCENT REAMER |
| 03700386974199 | CRESCENT REAMER |
| 03700386974182 | CRESCENT REAMER |
| 03700386974175 | CRESCENT REAMER |
| 03700386974168 | CRESCENT REAMER |