| Primary Device ID | 07649994217037 |
| NIH Device Record Key | 95c8428b-ff0a-4f4f-8bfd-dde2dca0d30f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T1D1 |
| Version Model Number | RX.X.X |
| Company DUNS | 484668533 |
| Company Name | Comerge AG |
| 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 | 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 | true |