GALILEI 410.030.007

GUDID 07640167751242

Galilei G6 Lens Professional

SIS AG, Surgical Instrument Systems

Optical low coherence reflectometry (OLCR) biometer

• Primary Device ID: 07640167751242
• NIH Device Record Key: f52a5a82-27db-4816-9e81-3a892ba413ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALILEI
• Version Model Number: G6
• Catalog Number: 410.030.007
• 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

• Handling Environment Atmospheric Pressure: Between 690 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167751242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182659

FDA Product Code

• MXK: Device, Analysis, Anterior Segment

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-30
• Device Publish Date: 2019-09-20

On-Brand Devices [GALILEI]

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