GALILEI

Basic Information

• Brand Name: GALILEI
• Primary DI: 07640167751242
• Version / Model: G6
• Catalog Number: 410.030.007
• Company Name: SIS AG, Surgical Instrument Systems
• Labeler DUNS: 480508261
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-20
• Public Version: 1
• Public Version Date: 2019-09-30
• Public Version Status: New
• Public Device Record Key: f52a5a82-27db-4816-9e81-3a892ba413ea

Device Description

Galilei G6 Lens Professional

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MXK	Device, Analysis, Anterior Segment	Ophthalmic	886.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48064	Optical low coherence reflectometry (OLCR) biometer	A mains electricity (AC-powered) ophthalmic device (a biometer) designed to determine the axial dimensions and frontal section of the eye including other biometric parameters/evaluations such as keratometry, white-to-white distance, pupillometry and consequently corneal power based on optical low coherence reflectometry (OLCR), non contact, measurement methods using light markers and digital image processing. It is normally adjustable on a cross stage with an integral chin rest and used to obtain measurements directly from the eye for processing and display via software, e.g., in an attached computer. Patient intraocular lens (IOL) suitability may also be calculated using different formulae.	No	Active
45729	Eye anterior segment analyser	A mains electricity (AC-powered) ophthalmic instrument intended to be used to measure and evaluate various properties of the anterior segment (i.e., cornea, iris, pupil, anterior chamber and lens). It is typically used for corneal topography, pachymetry, pupillometry and three-dimensional (3-D) analysis of the anterior eye segment using, e.g., revolving dual-channel Scheimpflug photography (viewing of the anterior segment in a sagittal plane) and Placido imaging (involves a disk with concentric white and black rings). It is typically computerized and provides output to a computer, with installed dedicated application software; the software may be included.	No	Active
45735	Corneal topography system application software	An individual software application program or group of programs, routines or algorithms intended to add specific computer assisted display, processing and/or analysis capabilities to a corneal topography system or system analyser. A basic set of applications programs and routines are included with such systems and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640167751242	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K182659	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 690 – 1060 millibar