| Primary Device ID | 10841307118909 |
| NIH Device Record Key | 0e317a89-257b-429d-be0a-ab002f96d6fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | simplyFixed RePlant® |
| Version Model Number | 6043-64K |
| Catalog Number | 6043-64K |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |