| Primary Device ID | EPRCA1000768 |
| NIH Device Record Key | 5cf10af9-fc96-48a2-8d37-ddf094d2be35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRO3DURE PR-1 |
| Version Model Number | 250 g - red opaque |
| Catalog Number | A1000768 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EPRCA1000768 [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 | 2022-10-28 |
| Device Publish Date | 2022-10-20 |
| EPRCA1000500 | light-curing pouring resin |
| EPRCA1000550 | light-curing pouring resin |
| EPRCA1000534 | light-curing pouring resin |
| EPRCA1000529 | light-curing pouring resin |
| EPRCA1000504 | light-curing pouring resin |
| EPRCA1000503 | light-curing pouring resin |
| EPRCA1000502 | light-curing pouring resin |
| EPRCA1000751 | light-curing pouring resin |
| EPRCA1000750 | light-curing pouring resin |
| EPRCA1000740 | light-curing pouring resin |
| EPRCA1000734 | light-curing pouring resin |
| EPRCA1000732 | light-curing pouring resin |
| EPRCA1000731 | light-curing pouring resin |
| EPRCA1000729 | light-curing pouring resin |
| EPRCA1000720 | light-curing pouring resin |
| EPRCA1000710 | light-curing pouring resin |
| EPRCA1000704 | light-curing pouring resin |
| EPRCA1000703 | light-curing pouring resin |
| EPRCA1000702 | light-curing pouring resin |
| EPRCA1000700 | light-curing pouring resin |
| EPRCA1000650 | light-curing pouring resin |
| EPRCA1000640 | light-curing pouring resin |
| EPRCA1000634 | light-curing pouring resin |
| EPRCA1000632 | light-curing pouring resin |
| EPRCA1000631 | light-curing pouring resin |
| EPRCA1000629 | light-curing pouring resin |
| EPRCA1000620 | light-curing pouring resin |
| EPRCA1000610 | light-curing pouring resin |
| EPRCA1000604 | light-curing pouring resin |
| EPRCA1000603 | light-curing pouring resin |
| EPRCA1000602 | light-curing pouring resin |
| EPRCA1000600 | light-curing pouring resin |
| EPRCA1000591 | light-curing pouring resin |
| EPRCA1000590 | light-curing pouring resin |
| EPRCA1000580 | light-curing pouring resin |
| EPRCA1000532 | light-curing pouring resin |
| EPRCA1000531 | light-curing pouring resin |
| EPRCA1000770 | light-curing pouring resin |
| EPRCA1000769 | light-curing pouring resin |
| EPRCA1000768 | light-curing pouring resin |
| EPRCA1000767 | light-curing pouring resin |
| EPRCA1000766 | light-curing pouring resin |
| EPRCA1000765 | light-curing pouring resin |
| EPRCA1000764 | light-curing pouring resin |
| EPRCA1000763 | light-curing pouring resin |
| EPRCA1000762 | light-curing pouring resin |
| EPRCA1000761 | light-curing pouring resin |
| EPRCA1000760 | light-curing pouring resin |
| EPRCA1000759 | light-curing pouring resin |
| EPRCA1000758 | light-curing pouring resin |