BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Palium Automatic reusable gun for soft tissue biopsy

    Reg #: 3004749705 · FEI: 3004749705 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    M.D.L. S.R.L.
    Registration Number
    3004749705
    FEI Number
    3004749705
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Tavani 1/a
    City
    Delebio (So) Sondrio
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K160316

    Owner / Operator

    Firm Name
    M.D.L. S.r.l.
    Operator Number
    10047695
    Address
    Via Tavani 1/a
    City
    Delebio (So)
    State
    Sondrio
    Postal Code
    23014
    Country
    IT
    Correspondent
    Marcello Dell 'Oca

    US Agent

    Business Name
    Followell Compliance Consultants LLC
    Contact Name
    Valerie Followell
    Address
    8049 Tripp Avenue
    City
    Skokie
    State
    IL
    ZIP
    60076
    Country
    US
    Email
    [email protected]
    Phone
    847 4006187

    Products

    Device Name Product Code
    Biopsy Needle FCG
    Instrument, Biopsy KNW

    Proprietary Names

    Palium Automatic reusable gun for soft tissue biopsy THEMY Automatic needle XXGxYYYmm for soft tissue biopsy. Notch 20mm INTRO Coaxial introducer needle XXG for needles XXG SEMICUT Semiautomatic guillotine needle XXGxYYYmm for soft tissues biopsy without removable Luer PALIUM NEEDLE Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium EASYCUT Semiautomatic needle XXGxYYYmm for cytohistological biopsy by aspiration as for Menghini modified

    Establishment Types

    Manufacture Medical Device