| Primary Device ID | 07290110722258 |
| NIH Device Record Key | 4ad4b1d9-bcbb-4add-b8d0-adb3e2f96b79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRI-OR |
| Version Model Number | TRI-OR 1.8-10mm |
| Catalog Number | TRI-OR 1.8-10 |
| 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 |