BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tor 3 Black

    DI: 07350075028922 · Model: 8922 · Leloi AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tor 3 Black
    Primary DI
    07350075028922
    Version / Model
    8922
    Company Name
    Leloi AB
    Labeler DUNS
    508701849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-26
    Public Version
    1
    Public Version Date
    2023-07-04
    Public Version Status
    New
    Public Device Record Key
    ea9fa408-392c-4ded-bd98-c8ab054e00a3

    Device Description

    Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasure. The ring shall be able to be placed around the penis at the base, primarily to slow the flow of blood from the erect penile tissue, thus maintaining an erection for a much longer period of time. Plus a vibrator to facilitate human sexual pleasure.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LKY Device, External Penile Rigidity

    GMDN Terms

    Code Name
    46334 Penile ring

    Identifiers

    Type ID
    Primary 07350075028922