| Primary Device ID | 09348215116316 |
| NIH Device Record Key | 2357f998-7add-4c7b-8c9b-e36c0d649d0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | World Knee CR All Poly Tibia |
| Version Model Number | 121-20-6719 |
| 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 | 09348215116316 [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 |
| 09348215116255 | 121-20-6119 |
| 09348215116330 | 121-20-6919 |
| 09348215116323 | 121-20-6819 |
| 09348215116316 | 121-20-6719 |
| 09348215116309 | 121-20-6619 |
| 09348215116293 | 121-20-6519 |
| 09348215116286 | 121-20-6419 |
| 09348215116279 | 121-20-6319 |
| 09348215116262 | 121-20-6219 |
| 09348215116064 | 121-20-6918 |
| 09348215116057 | 121-20-6818 |
| 09348215116040 | 121-20-6718 |
| 09348215116033 | 121-20-6618 |
| 09348215116026 | 121-20-6518 |
| 09348215116019 | 121-20-6418 |
| 09348215116002 | 121-20-6318 |
| 09348215115999 | 121-20-6128 |
| 09348215115982 | 121-20-6118 |