| Primary Device ID | EPRCA1001601 |
| NIH Device Record Key | 5fa65240-bd22-4983-ae9a-bd7f68a2ca75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | audioprint HPR-1 |
| Version Model Number | 1000 g bottle, White Opaque |
| Catalog Number | A1001601 |
| 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 |