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    FDA Registration Active 🇺🇸 United States

    Stylet 9735428 2 Coil Single Package

    Reg #: 1225492 · FEI: 3001237338 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NextPhase Medical Devices LLC
    Registration Number
    1225492
    FEI Number
    3001237338
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    88 Airport Dr
    City
    ROCHESTER
    State
    NH
    ZIP
    03867
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141833

    Owner / Operator

    Firm Name
    NextPhase Medical Devices LLC
    Operator Number
    9026654
    Address
    88 AIRPORT DR.
    City
    Rochester
    State
    NH
    Postal Code
    03867
    Country
    US
    Correspondent
    James G Bennett

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    Stylet 9735428 2 Coil Single Package Shunt Kit 9733606 Skull Mounted 9733606-G02 Shunt Kit 9733606 Skull Mounted Patient Tracker 9734887XOM Non-Invasive Shunt Kit 9733605 Non-Invasive BIT 9733519 3MM Cannulated Sterile BIT 9733517 3MM Drill Sterile Patient Tracker 9734887 Non-Invasive BIT 9733518 3.5MM Drill Sterile Patient Tracker 9735300 Skull Mount PKGD

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)