| Primary Device ID | 09348215056759 |
| NIH Device Record Key | 806be37d-05b6-4bc2-b56e-32e4d871459c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tibial Trial Insert Shim 14.5 |
| Version Model Number | 122-102-230 |
| 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 | false |
| 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 |