BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hyper Tough

    DI: 00666197824272 · Model: HTS-617113SM · Eye Ojo Corp.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hyper Tough
    Primary DI
    00666197824272
    Version / Model
    HTS-617113SM
    Company Name
    Eye Ojo Corp.
    Labeler DUNS
    041192266
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-06
    Public Version
    1
    Public Version Date
    2023-06-14
    Public Version Status
    New
    Public Device Record Key
    df923359-6b1b-47f1-9d4b-8ea59d0b126e

    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
    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
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

    GMDN Terms

    Code Name
    64958 Eye splash shield, reusable

    Identifiers

    Type ID
    Primary 00666197824272