Primary Device ID | 09348215111618 |
NIH Device Record Key | f8e56b76-c210-4f8c-8523-74e1bd12f702 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rx Knee All Poly Tibia Augment - Half - 4mm |
Version Model Number | 121-20-9278 |
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 | 09348215111618 [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 |
09348215111625 | 121-20-9279 |
09348215111618 | 121-20-9278 |
09348215111601 | 121-20-9277 |
09348215111595 | 121-20-9276 |
09348215111588 | 121-20-9275 |
09348215111571 | 121-20-9274 |
09348215111564 | 121-20-9273 |
09348215111557 | 121-20-9272 |
09348215111540 | 121-20-9271 |
09348215110598 | 121-20-9199 |
09348215110581 | 121-20-9198 |
09348215110574 | 121-20-9197 |
09348215110567 | 121-20-9196 |
09348215110550 | 121-20-9195 |
09348215110543 | 121-20-9194 |
09348215110536 | 121-20-9193 |
09348215110529 | 121-20-9192 |
09348215110512 | 121-20-9191 |