| Primary Device ID | 09348215116095 |
| NIH Device Record Key | 0e9287ce-b629-4e36-9f4d-528ad8c6e14f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | World Knee PS All Poly Tibia |
| Version Model Number | 121-20-6308 |
| 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 | 09348215116095 [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 | 2023-08-01 |
| Device Publish Date | 2023-07-24 |
| 09348215116422 | 121-20-6909 |
| 09348215116415 | 121-20-6809 |
| 09348215116408 | 121-20-6709 |
| 09348215116392 | 121-20-6609 |
| 09348215116385 | 121-20-6509 |
| 09348215116378 | 121-20-6409 |
| 09348215116125 | 121-20-6608 |
| 09348215116095 | 121-20-6308 |
| 09348215116361 | 121-20-6309 |
| 09348215116354 | 121-20-6209 |
| 09348215116347 | 121-20-6109 |
| 09348215116156 | 121-20-6908 |
| 09348215116149 | 121-20-6808 |
| 09348215116132 | 121-20-6708 |
| 09348215116118 | 121-20-6508 |
| 09348215116101 | 121-20-6408 |
| 09348215116088 | 121-20-6208 |
| 09348215116071 | 121-20-6108 |