BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SKYN

    DI: 08859798108441 · Model: 08859798108441 · SURETEX LIMITED - BRANCH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SKYN
    Primary DI
    08859798108441
    Version / Model
    08859798108441
    Company Name
    SURETEX LIMITED - BRANCH
    Labeler DUNS
    672044515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-27
    Public Version
    1
    Public Version Date
    2026-02-04
    Public Version Status
    New
    Public Device Record Key
    90dfb7cf-606f-4de7-93ad-907e5a6a1dfe

    Device Description

    SKYN Supreme Non-Latex Condom 1ct

    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
    Yes
    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 08859798108441

    Premarket Submissions

    Submission Number Supplement Number
    K231908 000