PMMA

Basic Information

• Brand Name: PMMA
• Primary DI: 00858174006003
• Version / Model: 003
• Company Name: LAGADO CORPORATION, THE
• Labeler DUNS: 109884150
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 73399476-58cb-47ab-a9a2-2ac48efda11e

Device Description

PMMA (polymethyl methacrylate) hard contact lens for daily wear

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HPX	Lens, Contact (Polymethylmethacrylate)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47839	Hard corrective contact lens	A rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia). The device is made of polymethylmethacrylate (PMMA), also known as Plexiglas or Lucite, and does not permit diffusion of oxygen (O2) to the ocular surface. These lenses are virtually obsolete and rarely used. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858174006003	GS1

Premarket Submissions

Submission Number	Supplement Number
K895411	000