AccessGUDID - DEVICE: Paraperm O2 (B22202)

GUDID

Device Identifier (DI) Information

Brand Name: Paraperm O2
Version or Model: Paraperm O2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Paragon Vision Sciences, Inc.

Primary DI Number: B22202
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 028594987 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47840	Rigid-gas-permeable corrective contact lens, daily-wear	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); 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. The lens may last for years and is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQD	Lens, Contact (Other Material) - Daily
HPX	Lens, Contact (Polymethylmethacrylate)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P820063	001
P820063	002
P820063	004
P820063	005
P820063	006
P820063	007
P820063	008
P820063	009
P820063	010
P820063	011
P820063	012
P820063	013
P820063	014
P820063	015
P820063	016
P820063	017
P820063	018
P820063	019
P820063	020
P820063	022
P820063	024
P820063	025
P820063	028
P820063	030
P820063	032
P820063	035
P820063	036
P820063	037
P820063	038
P820063	039
P820063	040
P820063	041
P820063	042
P820063	043
P820063	044
P820063	045
P820063	046
P820063	047
P820063	048
P820063	049
P820063	050
P820063	051
P820063	052
P820063	053
P820063	054

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce284c96-5a91-42db-8f6e-2fce2368e05a
Public Version Date: November 11, 2024
Public Version Number: 6
DI Record Publish Date: February 23, 2018