| Primary Device ID | EPRCA1040441 |
| NIH Device Record Key | 7a7e5365-035f-410e-9603-644aa4e14e5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | audioprint L-1 I MSI |
| Version Model Number | 100 g - Clear Transparent |
| Catalog Number | A1040441 |
| Company DUNS | 312947842 |
| Company Name | pro3dure medical 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EPRCA1040441 [Primary] |
| ESD | Hearing Aid, Air Conduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-26 |
| Device Publish Date | 2023-10-18 |
| EPRCA1040441 | audioprint L-1 I MSI, 100 g; clear transparent |
| EPRCA1040440 | audioprint L-1 I MSI, 50g; clear transparent |