| Primary Device ID | 09348215038083 |
| NIH Device Record Key | 1538baad-dcb6-4d49-acfb-32f0ebbaf2e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trial UniPolar Head |
| Version Model Number | 112-33-0013 |
| 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 | 09348215038083 [Primary] |
| HWT | Template |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09348215038083]
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 | 2018-10-02 |
| 09348215038229 | 112-33-0069 |
| 09348215038212 | 112-33-0068 |
| 09348215038205 | 112-33-0058 |
| 09348215038199 | 112-33-0057 |
| 09348215038182 | 112-33-0056 |
| 09348215038175 | 112-33-0055 |
| 09348215038168 | 112-33-0054 |
| 09348215038151 | 112-33-0053 |
| 09348215038144 | 112-33-0052 |
| 09348215038137 | 112-33-0051 |
| 09348215038120 | 112-33-0050 |
| 09348215038113 | 112-33-0049 |
| 09348215038106 | 112-33-0048 |
| 09348215038090 | 112-33-0014 |
| 09348215038083 | 112-33-0013 |
| 09348215038076 | 112-33-0012 |
| 09348215038069 | 112-33-0011 |
| 09348215038052 | 112-33-0010 |
| 09348215038045 | 112-33-0009 |
| 09348215038038 | 112-33-0008 |
| 09348215038021 | 112-33-0007 |