| Primary Device ID | 09348215004118 |
| NIH Device Record Key | c1964cd9-7b63-43a4-976d-d082ecc38927 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Signature BiPolar Head |
| Version Model Number | 111-21-2858 |
| 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 | 09348215004118 [Primary] |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2015-09-28 |
| 09348215017323 | 111-21-2242 |
| 09348215017316 | 111-21-2241 |
| 09348215017309 | 111-21-2240 |
| 09348215017293 | 111-21-2842 |
| 09348215004125 | 111-21-2859 |
| 09348215004118 | 111-21-2858 |
| 09348215004101 | 111-21-2857 |
| 09348215004095 | 111-21-2856 |
| 09348215004088 | 111-21-2855 |
| 09348215004071 | 111-21-2854 |
| 09348215004064 | 111-21-2853 |
| 09348215004057 | 111-21-2852 |
| 09348215004040 | 111-21-2851 |
| 09348215004033 | 111-21-2850 |
| 09348215004026 | 111-21-2849 |
| 09348215004019 | 111-21-2848 |
| 09348215004002 | 111-21-2847 |
| 09348215003999 | 111-21-2846 |
| 09348215003982 | 111-21-2845 |
| 09348215003975 | 111-21-2844 |
| 09348215003968 | 111-21-2843 |