| Primary Device ID | 09348215116507 |
| NIH Device Record Key | 2633a240-598c-4830-b814-dfbad1121c70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | World Knee UC All Poly Tibia |
| Version Model Number | 121-20-6839 |
| 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 | 09348215116507 [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 | 2023-08-07 |
| Device Publish Date | 2023-07-28 |
| 09348215116170 | 121-20-6238 |
| 09348215116163 | 121-20-6138 |
| 09348215116514 | 121-20-6939 |
| 09348215116507 | 121-20-6839 |
| 09348215116491 | 121-20-6739 |
| 09348215116484 | 121-20-6639 |
| 09348215116477 | 121-20-6539 |
| 09348215116460 | 121-20-6439 |
| 09348215116453 | 121-20-6339 |
| 09348215116446 | 121-20-6239 |
| 09348215116439 | 121-20-6139 |
| 09348215116248 | 121-20-6938 |
| 09348215116231 | 121-20-6838 |
| 09348215116224 | 121-20-6738 |
| 09348215116217 | 121-20-6638 |
| 09348215116200 | 121-20-6538 |
| 09348215116194 | 121-20-6438 |
| 09348215116187 | 121-20-6338 |