Primary Device ID | 09348215111397 |
NIH Device Record Key | 8fb11a67-a58b-44fe-ab70-14c8dece2e31 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rx Knee All Poly Tibia Augment - Full - 8mm |
Version Model Number | 121-20-9254 |
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 | 09348215111397 [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 |
09348215111441 | 121-20-9259 |
09348215111434 | 121-20-9258 |
09348215111427 | 121-20-9257 |
09348215111410 | 121-20-9256 |
09348215111403 | 121-20-9255 |
09348215111397 | 121-20-9254 |
09348215111380 | 121-20-9253 |
09348215111373 | 121-20-9252 |
09348215111366 | 121-20-9251 |
09348215110413 | 121-20-9179 |
09348215110406 | 121-20-9178 |
09348215110390 | 121-20-9177 |
09348215110383 | 121-20-9176 |
09348215110376 | 121-20-9175 |
09348215110369 | 121-20-9174 |
09348215110352 | 121-20-9173 |
09348215110345 | 121-20-9172 |
09348215110338 | 121-20-9171 |