| Primary Device ID | 00886385027081 |
| NIH Device Record Key | f9a295e0-2377-41f1-b962-f8452fb629d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 901-0125 |
| Catalog Number | 901-0125 |
| Company DUNS | 481999654 |
| Company Name | Stryker Trauma SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886385027081 [Primary] |
| NTG | Prosthesis, ankle, uncemented, non-constrained |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00886385027081]
Moist Heat or Steam Sterilization
[00886385027081]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2015-09-24 |
| 04546540520388 - NA | 2024-04-19 5 STEP REFERENCE CHART DISTAL TARGETING |
| 07613327614879 - VARIAX | 2024-04-19 Extended Volar DR Plate, standard, L |
| 07613327614886 - VARIAX | 2024-04-19 Wrist Add-on, Top Drawer Clip |
| 07613327614909 - VARIAX | 2024-04-19 Volar Distal Radius Plate Insert, Left |
| 07613327614916 - VARIAX | 2024-04-19 Extended Volar DR Plate, wide, R |
| 07613327614930 - VARIAX | 2024-04-19 Extended Volar DR Plate, narrow, L |
| 07613327614954 - VARIAX | 2024-04-19 Volar DR Plate, standard, L |
| 07613327614961 - VARIAX | 2024-04-19 Volar DR Plate, wide, R |