ACUVUE Abiliti overnight for myopia management with astigmatism

GUDID 00192538951364

MENICON CO.,LTD.

Orthokeratology contact lens
Primary Device ID00192538951364
NIH Device Record Key87d8c7ab-ce8a-41f7-8ed8-ae7cddb7bffa
Commercial Distribution StatusIn Commercial Distribution
Brand NameACUVUE Abiliti overnight for myopia management with astigmatism
Version Model NumberACUVUE Abiliti
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
GS100192538951364 [Primary]

FDA Product Code

NUULens, Contact, Orthokeratology, Overnight

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-02
Device Publish Date2022-01-25

Devices Manufactured by MENICON CO.,LTD.

00192538901086 - MeniconZ (tisilfocon A) Red2023-06-19
00192538951357 - ACUVUE Abiliti Overnight Therapeutic lenses for myopia management2022-02-02
00192538951364 - ACUVUE Abiliti overnight for myopia management with astigmatism2022-02-02
00192538951364 - ACUVUE Abiliti overnight for myopia management with astigmatism2022-02-02
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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