Primary Device ID | 09348215020262 |
NIH Device Record Key | 8bb95212-6e3e-44bc-8db2-13b4a3c4cb28 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Genius Total Knee System |
Version Model Number | 121-07-4000 |
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 |