Home GUDID B22202 Paraperm O2
Primary DI B22202
Brand Paraperm O2
Company Paragon Vision Sciences, Inc.
Model Paraperm O2
Device description Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Paraperm® O2 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® O2 rigid gas permeable tinted lenses offer a handling aid for locating the lens.
Published 2018-02-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HPX Lens, Contact (Polymethylmethacrylate) HQD Lens, Contact (Other Material) - Daily
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HPX Lens, Contact (Polymethylmethacrylate) Unknown U HQD Lens, Contact (Other Material) - Daily Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B22202 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Rigid-gas-permeable corrective contact lens, daily-wear, non-customized A prefabricated (non-customized) 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); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.
Regulatory Flags# DUNS number 028594987 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B22221 Paragon Z CRT Paragon Z CRT 2021-04-05 B22222 Paragon Z CRT Dual Axis Paragon Z CRT Dual Axis 2021-04-05 B22203 Paraperm EW Paraperm EW 2018-02-23 B22211 FSA 38 FSA 38 2018-03-16 B22214 FSA 52 FSA 52 2018-03-16 B22215 SportSight GP SportSight GP 2018-02-23 B22216 HDS HI 1.54 HDS HI 1.54 2018-02-02 B222700 Single Lens BillBoard 700 2017-12-08 B222750 Bi-Lens BillBoard 750 2017-12-08 B22201 Optacryl 60 Optacryl 60 2017-10-24 B22225 Oxfore100 Oxfore100 2023-09-18 B22204 Fluoroperm 92 Fluoroperm 92 2018-03-23 B22205 Fluoroperm 60 Fluoroperm 60 2018-03-23 B22206 Fluoroperm 30 Fluoroperm 30 2018-03-23 B22207 Fluoroperm 151 Fluoroperm 151 2018-03-23 B22208 Paragon HDS Paragon HDS 2018-03-23 B22209 Paragon HDS100 Paragon HDS100 2018-03-23 B22212 Paragon Thin Paragon Thin 2018-03-23 B22217 Paragon CRT Paragon CRT 2021-04-05 B22218 Paragon CRT100 Paragon CRT 100 2021-04-05
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