| Primary Device ID | EDWAT100452221 | 
| NIH Device Record Key | 95013f48-043a-48fa-8f48-3a2b21c15301 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Kera Ti5-Disc 98,5 x 22 mm | 
| Version Model Number | T10045222 | 
| 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 | 
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