BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Venus Viva - Diamondpolar applicator

    DI: 07290016540741 · Model: AS112010 · VENUS CONCEPT LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Venus Viva - Diamondpolar applicator
    Primary DI
    07290016540741
    Version / Model
    AS112010
    Company Name
    VENUS CONCEPT LTD
    Labeler DUNS
    533127663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-18
    Public Version
    2
    Public Version Date
    2020-06-12
    Public Version Status
    Update
    Public Device Record Key
    1dafd005-2247-43c8-bd3a-41a3065f28d9

    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
    No
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    58454 Radio-frequency skin surface treatment system

    Identifiers

    Type ID
    Package 07290016540697
    Primary 07290016540741

    Premarket Submissions

    Submission Number Supplement Number
    K150161 000
    K191065 000