BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    m.Dior.S Shock Shark Condoms

    DI: 06925634002258 · Model: 53±2mm · Suzhou Colourway New Material Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    m.Dior.S Shock Shark Condoms
    Primary DI
    06925634002258
    Version / Model
    53±2mm
    Company Name
    Suzhou Colourway New Material Co., Ltd.
    Labeler DUNS
    544612070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-22
    Public Version
    1
    Public Version Date
    2024-08-30
    Public Version Status
    New
    Public Device Record Key
    bebc0b13-b9a3-4cf1-9e3b-1f6542713bff

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIS Condom

    GMDN Terms

    Code Name
    45138 Basic male condom, Hevea-latex

    Identifiers

    Type ID
    Primary 06925634002258

    Premarket Submissions

    Submission Number Supplement Number
    K083817 000