BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NT990001 - Malleable Tunnelers 45 cm

    Reg #: 2023988 · FEI: 2023988 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Natus Medical Incorporated
    Registration Number
    2023988
    FEI Number
    2023988
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6225 Nancy Ridge Dr
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K932273

    Owner / Operator

    Firm Name
    Natus Medical Incorporated
    Operator Number
    9004873
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US
    Correspondent
    Sanjay Mehta

    Products

    Device Name Product Code
    Instrument, Shunt System Implantation GYK
    Shunt, Central Nervous System And Components JXG

    Proprietary Names

    NT990001 - Malleable Tunnelers 45 cm NT990010 - Malleable Tunnelers 65 cm

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198