| Primary Device ID | 09348215123864 |
| NIH Device Record Key | b3e3f179-7863-4f0f-874d-a72408d59f27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rx Knee All Poly Tibia Augment - Third |
| Version Model Number | 121-20-9336 |
| 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 | 09348215123864 [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 |
| 09348215123987 | 121-20-9329 |
| 09348215123970 | 121-20-9328 |
| 09348215123963 | 121-20-9327 |
| 09348215123956 | 121-20-9326 |
| 09348215123949 | 121-20-9325 |
| 09348215123932 | 121-20-9324 |
| 09348215123925 | 121-20-9323 |
| 09348215123918 | 121-20-9322 |
| 09348215123901 | 121-20-9321 |
| 09348215123895 | 121-20-9339 |
| 09348215123888 | 121-20-9338 |
| 09348215123871 | 121-20-9337 |
| 09348215123864 | 121-20-9336 |
| 09348215123857 | 121-20-9335 |
| 09348215123840 | 121-20-9334 |
| 09348215123833 | 121-20-9333 |
| 09348215123826 | 121-20-9332 |
| 09348215123819 | 121-20-9331 |