| Primary Device ID | 26970934720191 |
| NIH Device Record Key | e93995a0-81e7-46d5-a0d0-c64f1f0242f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Andorate Disposable Endoscope Bite Block (55.5 Fr) |
| Version Model Number | GAR059 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970934720197 [Primary] |
| GS1 | 16970934720194 [Package] Contains: 06970934720197 Package: Outer box [100 Units] In Commercial Distribution |
| GS1 | 26970934720191 [Package] Contains: 16970934720194 Package: Carton [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 | 2018-11-26 |
| Device Publish Date | 2018-10-24 |