BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Instrument ARM

    Reg #: 3014155960 · FEI: 3014155960 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Momentis Surgical Ltd.
    Registration Number
    3014155960
    FEI Number
    3014155960
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Yoni Netanyahu
    City
    Or Yehuda Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K250591

    Owner / Operator

    Firm Name
    Momentis Surgical Ltd.
    Operator Number
    10082179
    Address
    6 Yoni Netanyahu
    City
    Or Yehuda
    State
    Tel Aviv
    Postal Code
    6037604
    Country
    IL
    Correspondent
    Maya Leib Shlomo

    US Agent

    Business Name
    MedicSense USA LLC
    Contact Name
    George Hattub
    Address
    291 Hillside Avenue
    City
    Somerset
    State
    MA
    ZIP
    02726
    Country
    US
    Email
    [email protected]
    Phone
    508 4796116

    Products

    Device Name Product Code
    Mountable Electromechanical Surgical System For Transluminal Approaches QNM

    Proprietary Names

    Instrument ARM Unit Cable Surgeon Console 6Ne Pedal Energy Cable Robotic Control Unit 6Ne Vaginal Access Kit Pedestal Anovo Surgical System 6Ne

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198