Menicon Progent Large Diameter Contact Lens Case

GUDID 00192538901079

MENICON CO.,LTD.

Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case
Primary Device ID00192538901079
NIH Device Record Key9860a489-a5ee-45a9-bd7a-30bfff6c1551
Commercial Distribution StatusIn Commercial Distribution
Brand NameMenicon Progent Large Diameter Contact Lens Case
Version Model NumberBC-790+
Company DUNS690680533
Company NameMENICON CO.,LTD.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100192538901079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRXCase, Contact Lens

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-24

Devices Manufactured by MENICON CO.,LTD.

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00192538951364 - ACUVUE Abiliti overnight for myopia management with astigmatism2022-02-02
00192538901079 - Menicon Progent Large Diameter Contact Lens Case2021-10-04
00192538901079 - Menicon Progent Large Diameter Contact Lens Case2021-10-04
00192538901017 - Deluxe Scleral Lens Kit2020-05-11
00192538901024 - Deluxe Kit2020-05-11
00192538901031 - Basic Scleral Lens Kit2020-05-11
00884465603064 - Miru 1day Menicon Flat Pack TC CP302020-01-20

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