Pentacam AXL

GUDID 04049584012333

While rotating around the eye, the Pentacam® AXL captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Corneal topography system

• Primary Device ID: 04049584012333
• NIH Device Record Key: 374409a5-8836-4852-b570-f51c7a7e4866
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pentacam AXL
• Version Model Number: 70100
• Company DUNS: 317138956
• Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
• 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: 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: 7.9 Kilogram
• Height: 430 Millimeter
• Depth: 208 Millimeter
• Width: 270 Millimeter

Operating and Storage Conditions

• 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 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584012333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152311

FDA Product Code

• MXK: Device,Analysis,Anterior Segment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

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