BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    CereLink ICP Replacement Power Supply 826822

    Reg #: 3012507533 · FEI: 3012507533 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Integra Canada ULC
    Registration Number
    3012507533
    FEI Number
    3012507533
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2590 Bristol Circle, Unit 1
    City
    Oakville Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K232890

    Owner / Operator

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

    US Agent

    Business Name
    Integra LifeSciences Corporation
    Contact Name
    Jessica Smith
    Address
    1100 Campus Rd
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US
    Email
    [email protected]
    Phone
    385 7879990

    Products

    Device Name Product Code
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    CereLink ICP Replacement Power Supply 826822 CereLink ICP Extension Cable 826845 CereLink ICP Monitor 826820 CereLink ICP Replacement Battery 826824

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device