BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LIFESTYLES

    DI: 00070907030004 · Model: 3000 · SURETEX LIMITED - BRANCH
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    4
    Pkg Device Count
    36

    Basic Information

    Brand Name
    LIFESTYLES
    Primary DI
    00070907030004
    Version / Model
    3000
    Company Name
    SURETEX LIMITED - BRANCH
    Labeler DUNS
    672044515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    36
    Record Status
    Published
    Publish Date
    2019-08-29
    Public Version
    1
    Public Version Date
    2019-09-06
    Public Version Status
    New
    Public Device Record Key
    633051d7-d313-447b-92a1-d95f40cf0533

    Device Description

    LIFESTYLES PLEASURE COLLECTION 36CT (CONTAINS: SKYN ELITE, SKYN ORIGINAL, ULTRA SENSITIVE PLATINUM, ULTRA SENSITIVE AND ASSORTED FLAVORS)

    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
    MOL Condom, Synthetic
    HIS Condom

    GMDN Terms

    Code Name
    34151 Basic male condom, synthetic polymer
    45138 Basic male condom, Hevea-latex

    Identifiers

    Type ID
    Package 30070907030005
    Package 10070907030001
    Primary 00070907030004
    Unit of Use 80070907695681

    Premarket Submissions

    Submission Number Supplement Number
    K000408 000
    K160399 000
    K163107 000
    K941258 000