| Primary Device ID | 05055788781776 |
| NIH Device Record Key | 30912c13-70e9-4cac-8413-4721d6df3d7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DualGuard Endoscopy Mouthpiece Adult |
| Version Model Number | 032-10-870U |
| Company DUNS | 504406273 |
| Company Name | FLEXICARE MEDICAL LIMITED |
| 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 | 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 | 05055788781776 [Primary] |
| 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 | 2019-01-11 |
| Device Publish Date | 2018-12-11 |
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