| Primary Device ID | 09348215065133 |
| NIH Device Record Key | 428a2ee0-a714-4d48-b327-9267580195fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | World Cup Size 64mm |
| Version Model Number | 111-49-5064 |
| 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 | 09348215065133 [Primary] |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-15 |
| Device Publish Date | 2021-03-07 |
| 09348215124977 - 40mm Tib Drill | 2025-03-12 |
| 09348215124984 - 80mm Tib Drill | 2025-03-12 |
| 09348215125424 - V2 TRIVERSE TIBIAL TRAY PI | 2025-03-12 |
| 09348215127497 - V2 TRIVERSE TIBIAL TOWER | 2025-03-12 |
| 09348215127541 - V2 TRIVERSE PS BOX CUTTING JIG INSERT | 2025-03-12 |
| 09348215127572 - Patella Drill | 2025-03-12 |
| 09348215127589 - Femoral Lug Drill | 2025-03-12 |
| 09348215127619 - V2 TRIVERSE IMPACTOR FEMORAL | 2025-03-12 |