SportSight GP

GUDID B22215

SportSight GP (paflufocon C) intensely tinted rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lens

PARAGON VISION SCIENCES, INC.

Rigid-gas-permeable corrective contact lens, daily-wear
Primary Device IDB22215
NIH Device Record Keya682732f-ba80-4f68-a165-4800dfa82b53
Commercial Distribution StatusIn Commercial Distribution
Brand NameSportSight GP
Version Model NumberSportSight GP
Company DUNS185530029
Company NamePARAGON VISION SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB22215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQDLens, Contact (Other Material) - Daily

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-23

Devices Manufactured by PARAGON VISION SCIENCES, INC.

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B22218 - Paragon CRT1002021-04-13 Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congru
B22219 - Paragon CRT Dual Axis2021-04-13 Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon C
B22220 - Paragon RG-42021-04-13 Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consist
B22221 - Paragon Z CRT 2021-04-13 Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterio
B22222 - Paragon Z CRT Dual Axis 2021-04-13 Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congrue
B22202 - Paraperm O22019-05-06 Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact

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