GALILEI 410.030.004

GUDID 07640167751235

Galilei Dual Scheimpflug Analyzer

SIS AG, Surgical Instrument Systems

Optical low coherence reflectometry (OLCR) biometer

• Primary Device ID: 07640167751235
• NIH Device Record Key: 901acc33-c972-46b9-b547-5cb2340264a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALILEI
• Version Model Number: G4
• Catalog Number: 410.030.004
• Company DUNS: 480508261
• Company Name: SIS AG, Surgical Instrument Systems
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8667084490
• Email: usa@ziemergroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1080 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167751235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051940

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: 2016-09-15

On-Brand Devices [GALILEI]

• 07640167751235: Galilei Dual Scheimpflug Analyzer
• 07640167751242: Galilei G6 Lens Professional