| Primary Device ID | EDWAD100412131 |
| NIH Device Record Key | 78f40c09-0cea-4bde-9a2e-dd64d9268b72 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kera-Disc 98,3 x 13,5 mm |
| Version Model Number | D10041213 |
| Company DUNS | 344231006 |
| Company Name | Eisenbacher Dentalwaren ED 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |