BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LIFESTYLES

    DI: 00070907208724 · Model: 0872 · SURETEX LIMITED - BRANCH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    24

    Basic Information

    Brand Name
    LIFESTYLES
    Primary DI
    00070907208724
    Version / Model
    0872
    Company Name
    SURETEX LIMITED - BRANCH
    Labeler DUNS
    672044515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    24
    Record Status
    Published
    Publish Date
    2016-07-11
    Public Version
    8
    Public Version Date
    2023-07-31
    Public Version Status
    Update
    Public Device Record Key
    7d6db4dd-6616-471f-95d5-d97e065e584b

    Device Description

    LIFESTYLES ULTRA TRIAL 24CT (ULTRA SENSITIVE, ULTRA STUDDED, ULTRA RIBBED + 2 VIBRATING RINGS)

    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 00070907208724
    Unit of Use 80070907695575
    Package 10070907208721
    Package 30070907208725

    Premarket Submissions

    Submission Number Supplement Number
    K000408 000
    K941258 000