Primary Device ID | 09348215072384 |
NIH Device Record Key | 2b1451ce-c3ed-4216-8138-6db7eaa44081 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Genius Tibial Trial Monobloc PS - 11mm |
Version Model Number | 122-10-0911 |
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 | true |
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 | 09348215072384 [Primary] |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
[09348215072384]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-08-28 |
Device Publish Date | 2020-08-20 |