Menicon Unique pH Multi-Purpose Solution

Basic Information

• Brand Name: Menicon Unique pH Multi-Purpose Solution
• Primary DI: 00853253003065
• Version / Model: Travel Pack
• Company Name: MENICON AMERICA, INC.
• Labeler DUNS: 034212507
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-01-20
• Public Version Status: Update
• Public Device Record Key: 3db2730d-3b9b-4bb9-8d61-f64042265f17

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	886.5918	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48075	Multi-purpose rigid contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting rigid gas permeable (RGP) and hard contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). 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	00853253003065	GS1

Premarket Submissions

Submission Number	Supplement Number
K130805	000