| Primary Device ID | 09348215111595 |
| NIH Device Record Key | 38726fee-bc81-497c-a186-950894e04c3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rx Knee All Poly Tibia Augment - Half - 4mm |
| Version Model Number | 121-20-9276 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09348215111595 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-20 |
| Device Publish Date | 2024-11-12 |
| 09348215111625 | 121-20-9279 |
| 09348215111618 | 121-20-9278 |
| 09348215111601 | 121-20-9277 |
| 09348215111595 | 121-20-9276 |
| 09348215111588 | 121-20-9275 |
| 09348215111571 | 121-20-9274 |
| 09348215111564 | 121-20-9273 |
| 09348215111557 | 121-20-9272 |
| 09348215111540 | 121-20-9271 |
| 09348215110598 | 121-20-9199 |
| 09348215110581 | 121-20-9198 |
| 09348215110574 | 121-20-9197 |
| 09348215110567 | 121-20-9196 |
| 09348215110550 | 121-20-9195 |
| 09348215110543 | 121-20-9194 |
| 09348215110536 | 121-20-9193 |
| 09348215110529 | 121-20-9192 |
| 09348215110512 | 121-20-9191 |