BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ureteral Dilation Balloon

    Reg #: 1825146 · FEI: 1825146 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Cook Incorporated
    Registration Number
    1825146
    FEI Number
    1825146
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1100 W Morgan St
    City
    Spencer
    State
    IN
    ZIP
    47460
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040127

    Owner / Operator

    Firm Name
    COOK, INC.
    Operator Number
    1820334
    Address
    750 DANIELS WAY
    City
    Bloomington
    State
    IN
    Postal Code
    47404
    Country
    US

    Products

    Device Name Product Code
    Dilator, Catheter, Ureteral EZN

    Proprietary Names

    Ureteral Dilation Balloon Pursuit Balloon Dilation Catheter Ascent AQ Ureteral Dilation Balloon

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device