BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rough Rider

    DI: 08859798105013 · Model: 08859798105013 · 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
    Rough Rider
    Primary DI
    08859798105013
    Version / Model
    08859798105013
    Company Name
    SURETEX LIMITED - BRANCH
    Labeler DUNS
    672044515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-30
    Public Version
    1
    Public Version Date
    2025-08-07
    Public Version Status
    New
    Public Device Record Key
    2c2260af-a778-41d6-b833-ae0a1cb1563f

    Device Description

    Rough Rider 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
    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
    No
    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 08859798105013

    Premarket Submissions

    Submission Number Supplement Number
    K941258 000