| Primary Device ID | 09348215110314 |
| NIH Device Record Key | a7cbb751-30c4-495b-80e5-ff07b71b7cc1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rx Knee All Poly Tibia Augment - Full - 4mm |
| Version Model Number | 121-20-9168 |
| 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 | 09348215110314 [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 |
| 09348215111359 | 121-20-9249 |
| 09348215111342 | 121-20-9248 |
| 09348215111335 | 121-20-9247 |
| 09348215111328 | 121-20-9246 |
| 09348215111311 | 121-20-9245 |
| 09348215111304 | 121-20-9244 |
| 09348215111298 | 121-20-9243 |
| 09348215111281 | 121-20-9242 |
| 09348215111274 | 121-20-9241 |
| 09348215110321 | 121-20-9169 |
| 09348215110314 | 121-20-9168 |
| 09348215110307 | 121-20-9167 |
| 09348215110291 | 121-20-9166 |
| 09348215110284 | 121-20-9165 |
| 09348215110277 | 121-20-9164 |
| 09348215110260 | 121-20-9163 |
| 09348215110253 | 121-20-9162 |
| 09348215110246 | 121-20-9161 |