BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Steerable Introducer Sheath 8.5F

    Reg #: 1222140 · FEI: 1000121130 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FREUDENBERG MEDICAL, LLC
    Registration Number
    1222140
    FEI Number
    1000121130
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2301 Centennial Blvd
    City
    Jeffersonville
    State
    IN
    ZIP
    47130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191190

    Owner / Operator

    Firm Name
    Freudenberg Medical, LLC
    Operator Number
    9000550
    Address
    2301 Centennial Blvd., --
    City
    Jeffersonville
    State
    IN
    Postal Code
    47130
    Country
    US
    Correspondent
    Michael Kolesar

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Steerable Introducer Sheath 8.5F Steerable Introducer 8.5F

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device