BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ICU Eyewear

    DI: 00078041190264 · Model: 80450203 · ZOOM EYEWORKS DBA ICU EYEWEAR, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ICU Eyewear
    Primary DI
    00078041190264
    Version / Model
    80450203
    Company Name
    ZOOM EYEWORKS DBA ICU EYEWEAR, INC.
    Labeler DUNS
    001952241
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-01
    Public Version
    1
    Public Version Date
    2022-12-09
    Public Version Status
    New
    Public Device Record Key
    f9b1835d-6616-4462-8332-582a25547f58

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HQY Sunglasses (non-prescription including photosensitive)
    HOI Spectacle, magnifying

    GMDN Terms

    Code Name
    42832 Magnifying spectacles
    46297 Tinted non-prescription spectacle lens

    Identifiers

    Type ID
    Primary 00078041190264