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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Menicon Progent Large Diameter Contact Lens Case

    DI: 00192538901079 · Model: BC-790+ · MENICON CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Menicon Progent Large Diameter Contact Lens Case
    Primary DI
    00192538901079
    Version / Model
    BC-790+
    Company Name
    MENICON CO.,LTD.
    Labeler DUNS
    690680533
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-24
    Public Version
    1
    Public Version Date
    2021-10-04
    Public Version Status
    New
    Public Device Record Key
    9860a489-a5ee-45a9-bd7a-30bfff6c1551

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LRX Case, Contact Lens

    GMDN Terms

    Code Name
    16581 Contact lens case

    Identifiers

    Type ID
    Primary 00192538901079

    Premarket Submissions

    Submission Number Supplement Number
    K130285 000