Keratograph 5M

GUDID 04049584000477

The OCULUS Keratograph 5M combines the keratometric measuring process with topographic mapping. Measurement of the corneal surface is done by means of

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Corneal topography system

• 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

Device Dimensions

• Weight: 6.1 Kilogram
• Height: 512 Millimeter
• Depth: 400 Millimeter
• Width: 275 Millimeter

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04049584000477 [Primary]

FDA Product Code

• MMQ: Topographer, Corneal, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

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