| Primary Device ID | 04571328642303 |
| NIH Device Record Key | 36f090ad-0a29-42da-bd87-59fd01e2cd60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Binocular Indirect Ophthalmoscope |
| Version Model Number | IO-a LED CAMERA |
| Catalog Number | 205021 |
| Company DUNS | 690582325 |
| Company Name | NEITZ INSTRUMENTS CO.,LTD. |
| 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 | 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 800 millibar and 1060 millibar |