| Primary Device ID | 09348215134938 |
| NIH Device Record Key | be8b4151-bdc9-48dd-907f-9db81df4cbdc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Distal Centraliser Narrow |
| Version Model Number | 111-42-2003 |
| 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 | 09348215134938 [Primary] |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-13 |
| Device Publish Date | 2025-05-05 |
| 09348215134938 - Distal Centraliser Narrow | 2025-05-13 |
| 09348215134938 - Distal Centraliser Narrow | 2025-05-13 |
| 09348215134945 - Distal Centraliser Wide | 2025-05-13 |
| 09348215124960 - Tib Canal Reamer Bushing | 2025-04-17 |
| 09348215124991 - V2 TRVRSE ASYMM PATELLA TRIAL SIZE_28X6.2 | 2025-04-17 |
| 09348215125004 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 31X6.2 | 2025-04-17 |
| 09348215125011 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 31X8 | 2025-04-17 |
| 09348215125028 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 34X8.5 | 2025-04-17 |
| 09348215125035 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 37X10 | 2025-04-17 |