BEUDAMED
    FDA Registration Active 🇬🇹 Guatemala

    Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal

    Reg #: 3010452421 · FEI: 3010452421 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ortho and Surgical Products Enterprises S.A.
    Registration Number
    3010452421
    FEI Number
    3010452421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KM 20.5 Carretera a Villa Canales, Zona 3 Finca Morancito,
    City
    Villa Canales Guatemala
    Country
    GT

    Regulatory Submissions

    510(k) Number
    K994032

    Owner / Operator

    Firm Name
    DEROYAL INDUSTRIES, INC.
    Operator Number
    1044833
    Address
    200 DEBUSK LN., --
    City
    Powell
    State
    TN
    Postal Code
    37849
    Country
    US
    Correspondent
    Elizabeth Reed

    US Agent

    Business Name
    DeRoyal Industries, Inc.
    Contact Name
    Elizabeth Reed
    Address
    200 Debusk Ln
    City
    Powell
    State
    TN
    ZIP
    37849
    Country
    US
    Email
    [email protected]
    Phone
    865 3621256

    Products

    Device Name Product Code
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ

    Proprietary Names

    Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)