| Primary Device ID | E3120140023HP1 |
| NIH Device Record Key | 4a673c68-6072-46eb-8fc7-2fd5c4af72c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDENTA |
| Version Model Number | 0140.023HP |
| Company DUNS | 448002915 |
| Company Name | EDENTA ETABLISSEMENT |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |