| Primary Device ID | 09348215077167 |
| NIH Device Record Key | de9d450f-695f-4b26-827b-4764cb49be28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TLC Uni Knee Femoral Implant |
| Version Model Number | 121-21-1102 |
| 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 | 09348215077167 [Primary] |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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 | 2022-07-08 |
| Device Publish Date | 2022-06-30 |
| 09348215077266 | 121-21-1602 |
| 09348215077259 | 121-21-1601 |
| 09348215077242 | 121-21-1502 |
| 09348215077235 | 121-21-1501 |
| 09348215077228 | 121-21-1402 |
| 09348215077211 | 121-21-1401 |
| 09348215077204 | 121-21-1302 |
| 09348215077198 | 121-21-1301 |
| 09348215077181 | 121-21-1202 |
| 09348215077174 | 121-21-1201 |
| 09348215077167 | 121-21-1102 |
| 09348215077150 | 121-21-1101 |