| Primary Device ID | E3120041HP100101 |
| NIH Device Record Key | 06a1b5b3-0bf5-4e71-9b94-b2595c8f7e9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDENTA |
| Version Model Number | 0041HP-100 |
| Company DUNS | 448002915 |
| Company Name | EDENTA ETABLISSEMENT |
| Device Count | 100 |
| 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 |