| Primary Device ID | EDET043831 |
| NIH Device Record Key | 8b05f4a4-02c1-4dcd-bd6e-af4739af5f1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | earflex rose 25 shore 8x50ml |
| Version Model Number | 03483 |
| Company DUNS | 343947949 |
| Company Name | DETAX GmbH |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |