BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRUCLEAR Sheath 9

    Reg #: 1219930 · FEI: 1219930 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Covidien
    Registration Number
    1219930
    FEI Number
    1219930
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    60 Middletown Ave
    City
    North Haven
    State
    CT
    ZIP
    06473
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031787

    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
    Hysteroscope (And Accessories) HIH

    Proprietary Names

    TRUCLEAR Sheath 9 TRUCLEAR Operative Hysteroscope 8 TRUCLEAR Footswitch TRUCLEAR Tissue Removal System TRUCLEAR Handpiece TRUCLEAR INCISOR" Plus Tissue Removal Device TRUCLEAR Control Unit TRUCLEAR Obturator TRUCLEAR Operative Hysteroscope 8- Refurbished/Service TRUCLEAR INCISOR" Tissue Removal Device

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility