| Primary Device ID | 06970934720074 |
| NIH Device Record Key | 91de32c5-87e3-4b39-bfcf-2de11d87abef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Andorate |
| Version Model Number | GAR044 |
| Company DUNS | 544333811 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970934720074 [Primary] |
| GS1 | 16970934720071 [Package] Package: Outer box [100 Units] In Commercial Distribution |
| GS1 | 26970934720078 [Package] Contains: 16970934720071 Package: Outer case [4 Units] In Commercial Distribution |
| MNK | Endoscopic Bite Block |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-11 |
| Device Publish Date | 2018-09-10 |
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 |