| Primary Device ID | 04049584000477 |
| NIH Device Record Key | 1ca9393f-84b4-4601-afd6-6ef12318353a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Keratograph 5M |
| Version Model Number | 7700 |
| Company DUNS | 317138956 |
| Company Name | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Weight | 6.1 Kilogram |
| Height | 512 Millimeter |
| Depth | 400 Millimeter |
| Width | 275 Millimeter |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| 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 80 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049584000477 [Primary] |
| MMQ | Topographer, Corneal, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-01 |