| Primary Device ID | EDWAD100411151 | 
| NIH Device Record Key | 82cffdc5-7b96-4b90-a3c2-4d712664e78e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Kera-Disc 99,5 x 15 mm | 
| Version Model Number | D10041115 | 
| 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 |