| Primary Device ID | D831TI10 |
| NIH Device Record Key | cbe7d1a1-79e3-42f6-959b-57b5f7f2c23c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREMIOtitan |
| Version Model Number | TI-10 |
| Company DUNS | 153454736 |
| Company Name | PRIMOTEC LLC |
| 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 | false |
| 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 |