Primary Device ID | 09348215111335 |
NIH Device Record Key | 8e800ef6-b832-4ecd-9f64-75e830d0a456 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rx Knee All Poly Tibia Augment - Full - 4mm |
Version Model Number | 121-20-9247 |
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 | 09348215111335 [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 |
09348215111359 | 121-20-9249 |
09348215111342 | 121-20-9248 |
09348215111335 | 121-20-9247 |
09348215111328 | 121-20-9246 |
09348215111311 | 121-20-9245 |
09348215111304 | 121-20-9244 |
09348215111298 | 121-20-9243 |
09348215111281 | 121-20-9242 |
09348215111274 | 121-20-9241 |
09348215110321 | 121-20-9169 |
09348215110314 | 121-20-9168 |
09348215110307 | 121-20-9167 |
09348215110291 | 121-20-9166 |
09348215110284 | 121-20-9165 |
09348215110277 | 121-20-9164 |
09348215110260 | 121-20-9163 |
09348215110253 | 121-20-9162 |
09348215110246 | 121-20-9161 |