BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PTFE PLEDGET

    Reg #: 2647580 · FEI: 2647580 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Covidien
    Registration Number
    2647580
    FEI Number
    2647580
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BUILDING 911-67, SABANETAS INDUSTRIAL PARK
    City
    PONCE
    State
    PR
    ZIP
    00731
    Country
    US

    Regulatory Submissions

    510(k) Number
    K953289

    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
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ

    Proprietary Names

    PTFE PLEDGET

    Establishment Types

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