WaveLight

Basic Information

• Brand Name: WaveLight
• Primary DI: 00380659982989
• Version / Model: 8065998298
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-05-15
• Public Version: 3
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 8bda8e8e-3f9c-409d-a4ac-8a3a5a4cc050

Device Description

WAVELIGHT FS200 PATIENT INTERFACE - EASYPACK (BOX OF 20)

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered laser surgical instrument	General, Plastic Surgery	878.4810	2
HNO	Keratome, ac-powered	Ophthalmic	886.4370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380659982989	GS1
Unit of Use	00380659982996	GS1

Customer Contacts

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