BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lifestyles

    DI: 00850002174274 · Model: GS104B · LUNAMAX LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Lifestyles
    Primary DI
    00850002174274
    Version / Model
    GS104B
    Company Name
    LUNAMAX LLC
    Labeler DUNS
    106855461
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-27
    Public Version
    1
    Public Version Date
    2018-12-28
    Public Version Status
    New
    Public Device Record Key
    f2442143-68cb-4a05-bbf6-b4c86a2d4c27

    Device Description

    Lifestyles Extra Strength Latex Condom

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIS Condom

    GMDN Terms

    Code Name
    45138 Basic male condom, Hevea-latex

    Identifiers

    Type ID
    Primary 00850002174274

    Premarket Submissions

    Submission Number Supplement Number
    K941258 000