| Primary Device ID | EDET038421 |
| NIH Device Record Key | 96730988-719e-466c-8bca-ec99408ddf95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | luxaprint 3D shell white 500g |
| Version Model Number | 03842 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDET038421 [Primary] |
| ESD | Hearing Aid, Air-Conduction, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-05 |
| Device Publish Date | 2024-08-28 |
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