Infiniti

Basic Information

• Brand Name: Infiniti
• Primary DI: 00380657521609
• Version / Model: 8065752160
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 181e7b7d-fa1c-4b1c-af56-3d67cbac9b5a

Device Description

Infiniti Vision System

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: Yes
• 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
HQE	Instrument, vitreous aspiration and cutting, ac-powered	Ophthalmic	886.4150	2
HQC	Unit, phacofragmentation	Ophthalmic	886.4670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17596	Phacoemulsification system generator	A mains electricity (AC-powered) ophthalmic device that generates the energy (e.g., ultrasonic, piezoelectric) in a cataract extraction system. The energy is delivered through a handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed for the removal of debris.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380657521609	GS1

Customer Contacts

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