Primary Device ID | 09348215110642 |
NIH Device Record Key | 0ca526f0-439e-453d-ab6e-36992f2802b5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rx Knee All Poly Tibia Augment - Half - 8mm |
Version Model Number | 121-20-9205 |
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 | 09348215110642 [Primary] |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-20 |
Device Publish Date | 2024-11-12 |
09348215111717 | 121-20-9289 |
09348215111700 | 121-20-9288 |
09348215111694 | 121-20-9287 |
09348215111687 | 121-20-9286 |
09348215111670 | 121-20-9285 |
09348215111663 | 121-20-9284 |
09348215111656 | 121-20-9283 |
09348215111649 | 121-20-9282 |
09348215111632 | 121-20-9281 |
09348215110680 | 121-20-9209 |
09348215110673 | 121-20-9208 |
09348215110666 | 121-20-9207 |
09348215110659 | 121-20-9206 |
09348215110642 | 121-20-9205 |
09348215110635 | 121-20-9204 |
09348215110628 | 121-20-9203 |
09348215110611 | 121-20-9202 |
09348215110604 | 121-20-9201 |