BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Codman Accessories Neuro Monitor

    Reg #: 3014334038 · FEI: 3014334038 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Integra LifeSciences Production Corporation
    Registration Number
    3014334038
    FEI Number
    3014334038
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11 Cabot Blvd.
    City
    Mansfield
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K914479

    Owner / Operator

    Firm Name
    Integra LifeSciences Corporation
    Operator Number
    9004007
    Address
    1100 Campus Rd
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    Products

    Device Name Product Code
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    Codman Accessories Neuro Monitor Codman Accessories Drill Kit Codman Accessories Cables Codman Microsensor Intracranial Pressure Transducer and Accessories Codman Accessories Interface Control Unit Kit Codman Accessories Ventricular Kit Codman Accessories Cranial Access Kit Codman Accessories Bolt Kit Codman Accessories ICP Transducer Basic Kit Codman Microsensor

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility