BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900

    Reg #: 9612501 · FEI: 3003495548 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Covidien
    Registration Number
    9612501
    FEI Number
    3003495548
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZONA FRANCA DE SAN ISIDRO, Carretera San Isidro, Km 17
    City
    - Santo Domingo
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K010361

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    Products

    Device Name Product Code
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Cover, Burr Hole GXR

    Proprietary Names

    Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)