BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK

    DI: 07350075023453 · Model: 3453 · Leloi AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK
    Primary DI
    07350075023453
    Version / Model
    3453
    Company Name
    Leloi AB
    Labeler DUNS
    508701849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2022-05-27
    Public Version
    1
    Public Version Date
    2022-06-06
    Public Version Status
    New
    Public Device Record Key
    c1587153-1c6d-4e17-a45c-04fbeb9a0621

    Device Description

    The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    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
    Unit of Use 07350075025075
    Primary 07350075023453