BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LifeStyles SKYN Large 40 ct Bowl

    DI: 00813356000217 · Model: 813356000217 · PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LifeStyles SKYN Large 40 ct Bowl
    Primary DI
    00813356000217
    Version / Model
    813356000217
    Company Name
    PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
    Labeler DUNS
    038573838
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-21
    Public Version
    1
    Public Version Date
    2019-01-21
    Public Version Status
    New
    Public Device Record Key
    1c26946b-8e26-45a4-b05b-1d3b619b85b7

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MOL Condom, Synthetic

    GMDN Terms

    Code Name
    34151 Basic male condom, synthetic polymer

    Identifiers

    Type ID
    Primary 00813356000217

    Premarket Submissions

    Submission Number Supplement Number
    K160399 000