Optimum Comfort roflufocon C

GUDID 00865576000225

Rigid Gas Permeable Contact Lens

CONTAMAC HOLDINGS LIMITED

Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear Rigid-gas-permeable corrective contact lens, daily-wear
Primary Device ID00865576000225
NIH Device Record Keydc6e1d50-54e7-42b8-ba74-f3d6feb25c73
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimum Comfort
Version Model Numberroflufocon C
Catalog Numberroflufocon C
Company DUNS216236887
Company NameCONTAMAC HOLDINGS LIMITED
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
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]
GS100865576000225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily
HQDLens, Contact (Other Material) - Daily

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

Devices Manufactured by CONTAMAC HOLDINGS LIMITED

00865576000249 - Optimum HR 1.512020-08-05 Rigid Gas Permeable Contact Lens
00865576000256 - Optimum HR 1.532020-08-05 Rigid Gas Permeable Contact Lens
00865576000270 - Hybird FS2020-08-05 Rigid Gas Permeable Contact Lens
00865576000294 - Optimum Infinite2020-08-05 Rigid Gas Permeable Contact Lens
00865576000201 - Optimum Extra2020-07-30 Rigid Gas Permeable Contact Lens
00865576000218 - Optimum Extreme2020-07-30 Rigid Gas Permeable Contact Lens
00865576000225 - Optimum Comfort2020-07-30Rigid Gas Permeable Contact Lens
00865576000225 - Optimum Comfort2020-07-30 Rigid Gas Permeable Contact Lens
00865576000232 - Optimum Classic2020-07-30 Rigid Gas Permeable Contact Lens

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