BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    TraumaCad Neo 1.1

    Reg #: 3005225421 · FEI: 3005225421 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Brainlab Ltd.
    Registration Number
    3005225421
    FEI Number
    3005225421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    35 Efal Street
    City
    PETACH-TIKVA Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K243810

    Owner / Operator

    Firm Name
    Brainlab Ltd.
    Operator Number
    9074705
    Address
    35 Efal Street, --
    City
    PETACH TIKVA
    State
    IL-NOTA
    Postal Code
    4951132
    Country
    IL
    Correspondent
    Yael - Guttentag

    US Agent

    Business Name
    MEDICSENSE
    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
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    TraumaCad Neo 1.1

    Establishment Types

    Manufacture Medical Device