BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reprocessed Bi-Directional Guiding Sheath

    Reg #: 3011610434 · FEI: 3011610434 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INNOVATIVE HEALTH, LLC.
    Registration Number
    3011610434
    FEI Number
    3011610434
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1435 N. Hayden Road, Suite 100
    City
    Scottsdale
    State
    AZ
    ZIP
    85257
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212165

    Owner / Operator

    Firm Name
    Innovative Health, LLC.
    Operator Number
    10048854
    Address
    1435 N. Hayden Road, Suite 100
    City
    Scottsdale
    State
    AZ
    Postal Code
    85257
    Country
    US
    Correspondent
    Angelica McParlane

    Products

    Device Name Product Code
    Reprocessed Catheter Introducer PNE
    Introducer, Catheter DYB

    Proprietary Names

    Reprocessed Bi-Directional Guiding Sheath

    Establishment Types

    Reprocess Single-Use Device