| Primary Device ID | 09348215041533 |
| NIH Device Record Key | a682dadd-73a8-405a-8867-1d8c3d160563 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tibial Tray |
| Version Model Number | 122-10-0160 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 09348215041533 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09348215041533]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-06-13 |
| Device Publish Date | 2019-05-27 |
| 09348215041540 | 122-10-0161 |
| 09348215041533 | 122-10-0160 |
| 09348215041526 | 122-10-0159 |
| 09348215041519 | 122-10-0158 |
| 09348215041502 | 122-10-0157 |
| 09348215041496 | 122-10-0156 |
| 09348215041489 | 122-10-0155 |