Clear Eyes®

Basic Information

• Brand Name: Clear Eyes®
• Primary DI: 00678112653218
• Version / Model: CE063404, CE063104
• Company Name: Medtech Products Inc.
• Labeler DUNS: 060272465
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 8
• Public Version Date: 2023-07-03
• Public Version Status: Update
• Public Device Record Key: 88cae9b2-40ef-4923-877a-902826d15ba3

Device Description

Contact Lens Multi-Action Relief Lubricating Eye Drops for Contact Lens Wearers

Device Characteristics

• Single Use: No
• 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
44237	Eye lubricant	A substance intended to provide supplemental lubrication/hydration to the natural eye to treat dry, tired, irritated, and/or strained eyes resulting from dry eye syndrome, ageing/hormone changes (menopause), or environmental factors (e.g., medications, pollution, computer use, air conditioning, allergy); some types may in addition be intended to wet contact lenses during wear. It may be a topical solution, spray, suspension, or gel applied to the eyes or eyelids, and may have special formulations (e.g., intensive, night use). It is intended for use in the home or healthcare facility (single dose or multidose). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00678112664771	GS1	Shipping case	36	In Commercial Distribution
Primary	00678112653218	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P880056	002

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature