| Primary Device ID | 03760260221009 |
| NIH Device Record Key | ed61b101-3a29-4887-94e9-0889f59102be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOTALCEM |
| Version Model Number | A2 |
| Catalog Number | TTLCEM-A2 |
| Company DUNS | 278261221 |
| Company Name | ITENA CLINICAL |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |