| Primary Device ID | 07290110722203 |
| NIH Device Record Key | c57d0b16-0e81-49e2-8cac-ea1be0bf15a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRI |
| Version Model Number | TRI-11.5mmSR |
| Catalog Number | TRI-11.5SR |
| Company DUNS | 600710917 |
| Company Name | HI-TEC IMPLANTS LTD. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |