| Primary Device ID | B809M300000003000 |
| NIH Device Record Key | 240a4e35-1a00-41e4-b5ae-b79ebc17362b |
| Commercial Distribution Discontinuation | 2025-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Video Otoscope |
| Version Model Number | OX2 |
| Catalog Number | M-300-00000-3000 |
| Company DUNS | 341467978 |
| Company Name | orlvision GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
|---|---|
| HIBCC | B809M300000003000 [Primary] |
| ERA | Otoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-16 |
| Device Publish Date | 2020-03-06 |
| B809M105220300700 - Laryngoskop FS2 | 2020-10-27 This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage |
| B809M205220310101 - Flexible Video Rhino Laryngoscope | 2020-03-16 Flexible Video Rhino Laryngoscope, diameter flexible end 2,9 mm |
| B809M205240310101 - Flexible Video Rhino Laryngoscope | 2020-03-16 Flexible Video Rhino Laryngoscope |
| B809M300000003000 - Video Otoscope | 2020-03-16Flexible Video Otoscope for examination of the outer ear |
| B809M300000003000 - Video Otoscope | 2020-03-16 Flexible Video Otoscope for examination of the outer ear |
| B809M2052203101010 - Laryngoscope | 2020-03-09 Video Nasopharyngo-laryngoscope |