| Primary Device ID | 09348215111434 |
| NIH Device Record Key | e75480cd-25f9-44f5-b7b9-675519dcfbb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rx Knee All Poly Tibia Augment - Full - 8mm |
| Version Model Number | 121-20-9258 |
| 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 | 09348215111434 [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 |
| 09348215111441 | 121-20-9259 |
| 09348215111434 | 121-20-9258 |
| 09348215111427 | 121-20-9257 |
| 09348215111410 | 121-20-9256 |
| 09348215111403 | 121-20-9255 |
| 09348215111397 | 121-20-9254 |
| 09348215111380 | 121-20-9253 |
| 09348215111373 | 121-20-9252 |
| 09348215111366 | 121-20-9251 |
| 09348215110413 | 121-20-9179 |
| 09348215110406 | 121-20-9178 |
| 09348215110390 | 121-20-9177 |
| 09348215110383 | 121-20-9176 |
| 09348215110376 | 121-20-9175 |
| 09348215110369 | 121-20-9174 |
| 09348215110352 | 121-20-9173 |
| 09348215110345 | 121-20-9172 |
| 09348215110338 | 121-20-9171 |