| Primary Device ID | 09348215025861 |
| NIH Device Record Key | 4d57ddf5-30ee-4e2d-a868-ea0b0e77462a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fusion Taper Sleeve +8mm |
| Version Model Number | 111-37-0004 |
| Company DUNS | 751993028 |
| Company Name | SIGNATURE ORTHOPAEDICS PTY LTD |
| 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 |