| Primary Device ID | 09348215045517 |
| NIH Device Record Key | 3997bc86-a5e7-4644-bfd3-cf9a0fa95a3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trial BiPolar Head |
| Version Model Number | 112-24-0046 |
| 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 | 09348215045517 [Primary] |
| HWT | Template |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09348215045517]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-18 |
| Device Publish Date | 2018-10-05 |
| 09348215045494 | 112-24-0044 |
| 09348215045487 | 112-24-0043 |
| 09348215045470 | 112-24-0042 |
| 09348215045654 | 112-24-0060 |
| 09348215045647 | 112-24-0059 |
| 09348215045630 | 112-24-0058 |
| 09348215045623 | 112-24-0057 |
| 09348215045616 | 112-24-0056 |
| 09348215045609 | 112-24-0055 |
| 09348215045593 | 112-24-0054 |
| 09348215045586 | 112-24-0053 |
| 09348215045579 | 112-24-0052 |
| 09348215045562 | 112-24-0051 |
| 09348215045555 | 112-24-0050 |
| 09348215045548 | 112-24-0049 |
| 09348215045531 | 112-24-0048 |
| 09348215045524 | 112-24-0047 |
| 09348215045517 | 112-24-0046 |
| 09348215045500 | 112-24-0045 |