| Primary Device ID | 09348215077464 |
| NIH Device Record Key | 6eb1bce5-596d-4fbc-a18f-2ce41c122712 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TLC Uni Knee Meniscal Insert |
| Version Model Number | 121-21-2301 |
| 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 | 09348215077464 [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 |
| 09348215077723 | 121-21-2611 |
| 09348215077709 | 121-21-2601 |
| 09348215077686 | 121-21-2691 |
| 09348215077648 | 121-21-2511 |
| 09348215077624 | 121-21-2501 |
| 09348215077600 | 121-21-2591 |
| 09348215077563 | 121-21-2411 |
| 09348215077549 | 121-21-2401 |
| 09348215077525 | 121-21-2491 |
| 09348215077488 | 121-21-2311 |
| 09348215077464 | 121-21-2301 |
| 09348215077440 | 121-21-2391 |
| 09348215077402 | 121-21-2211 |
| 09348215077389 | 121-21-2201 |
| 09348215077365 | 121-21-2291 |
| 09348215077334 | 121-21-2111 |
| 09348215077310 | 121-21-2101 |
| 09348215077297 | 121-21-2191 |