| Primary Device ID | 00810044841572 |
| NIH Device Record Key | 74d06b23-f431-4b08-9f9a-57a538800623 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HexaPLUS S OneDrill Implant System |
| Version Model Number | HSF5213 |
| Company DUNS | 080694564 |
| Company Name | OSSEOFUSE INTERNATIONAL, INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |