OPTI-CLEAN

Basic Information

• Brand Name: OPTI-CLEAN
• Primary DI: 00300650104203
• Version / Model: OPTI-CLEAN 20ml
• 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: 11beb7a9-a036-4f38-8d27-5c3603ce7430

Device Description

OPTI-CLEAN II Daily Cleaner 20ml

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LPN	Accessories, soft lens products	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48083	Soft/rigid contact lens cleaning solution	An aqueous formulation containing appropriate agents for loosening debris from reusable soft, rigid gas permeable (RGP), and hard contact lenses, often with a gentle rubbing of the lenses, to clean the lenses prior to wear. This GMDN code does not include solutions that remove protein or disinfect. The device is used mainly for daily care of the lens. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00300650104203	GS1
Package	20300650104207	GS1	Case	24	In Commercial Distribution

Customer Contacts

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