| Primary Device ID | 09348215110611 |
| NIH Device Record Key | 47a8e4a2-d765-4a1c-9299-9bfa30ef9b52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rx Knee All Poly Tibia Augment - Half - 8mm |
| Version Model Number | 121-20-9202 |
| 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 | 09348215110611 [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 |
| 09348215111717 | 121-20-9289 |
| 09348215111700 | 121-20-9288 |
| 09348215111694 | 121-20-9287 |
| 09348215111687 | 121-20-9286 |
| 09348215111670 | 121-20-9285 |
| 09348215111663 | 121-20-9284 |
| 09348215111656 | 121-20-9283 |
| 09348215111649 | 121-20-9282 |
| 09348215111632 | 121-20-9281 |
| 09348215110680 | 121-20-9209 |
| 09348215110673 | 121-20-9208 |
| 09348215110666 | 121-20-9207 |
| 09348215110659 | 121-20-9206 |
| 09348215110642 | 121-20-9205 |
| 09348215110635 | 121-20-9204 |
| 09348215110628 | 121-20-9203 |
| 09348215110611 | 121-20-9202 |
| 09348215110604 | 121-20-9201 |