Primary Device ID | 14897106953643 |
NIH Device Record Key | 52ace984-b812-46c6-adc0-27d0f216e498 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | andorate® Eye Cornea Protectors |
Version Model Number | GAR001 |
Company DUNS | 686908512 |
Company Name | GA Health Company Limited |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04897106953646 [Primary] |
GS1 | 14897106953643 [Package] Contains: 04897106953646 Package: Box [100 Units] In Commercial Distribution |
GS1 | 24897106953640 [Package] Package: Carton [50 Units] In Commercial Distribution |
HMP | Pad, Eye |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-10 |
Device Publish Date | 2022-03-02 |
24897106953657 | GAR001-NP |
14897106953643 | GAR001 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ANDORATE 97445913 not registered Live/Pending |
GA HEALTH COMPANY LIMITED 2022-06-07 |
ANDORATE 97445874 not registered Live/Pending |
GA HEALTH COMPANY LIMITED 2022-06-07 |
ANDORATE 87709057 5589076 Live/Registered |
GA HEALTH COMPANY LIMITED 2017-12-05 |