| Primary Device ID | B634MON000005010 |
| NIH Device Record Key | c4c48d2d-a17a-46c6-8929-c9e9d6bc47df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monarch Endoscopy Platform (P1) Tower Upgrade |
| Version Model Number | MON-000005-01 |
| Company DUNS | 015823456 |
| Company Name | AURIS HEALTH, INC. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |