| Primary Device ID | 09348215031138 |
| NIH Device Record Key | 87f74e2f-73b8-4675-853d-e69fa00dca86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SignaSure Cemented Cup |
| Version Model Number | 111-27-0644 |
| 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 | 09348215031138 [Primary] |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-07 |
| Device Publish Date | 2022-01-28 |
| 09348215031237 | 111-27-0664 |
| 09348215031220 | 111-27-0662 |
| 09348215031213 | 111-27-0660 |
| 09348215031206 | 111-27-0658 |
| 09348215031190 | 111-27-0656 |
| 09348215031183 | 111-27-0654 |
| 09348215031176 | 111-27-0652 |
| 09348215031169 | 111-27-0650 |
| 09348215031152 | 111-27-0648 |
| 09348215031145 | 111-27-0646 |
| 09348215031138 | 111-27-0644 |
| 09348215031121 | 111-27-0642 |