| Primary Device ID | 08057432561632 |
| NIH Device Record Key | f378dd49-8f87-4f12-a710-6f76dc9073dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TFX / TRAUMAFIX |
| Version Model Number | TFX-21S63 |
| Company DUNS | 544150399 |
| Company Name | SINTEA PLUSTEK SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | false |
| OTC Over-The-Counter | false |