Menicon Progent Protein Remover

Basic Information

• Brand Name: Menicon Progent Protein Remover
• Primary DI: 00853253003034
• Version / Model: 1P
• 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: 1a11f5d7-69ff-49f3-a260-4bfa36b906bf

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
45599	Contact lens protein-removal solution	A formulation of proteolytic enzymes, that may or may not be dissolved in cleaning (and possibly disinfecting) contact lens solution, used to remove debris and protein deposits from reusable contact lenses, or to remove protein deposits only. The lenses are typically soaked for a period in the solution and then rinsed in fresh contact lens cleaning solution for the removal of any residual material. Protein build-up on contact lenses often occurs from tear secretion. 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	00853253003034	GS1

Premarket Submissions

Submission Number	Supplement Number
K122273	000