BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    Insufflator 50L FM134

    Reg #: 3020704423 · FEI: 3020704423 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Arthrex New Zealand Limited
    Registration Number
    3020704423
    FEI Number
    3020704423
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Fox Street
    City
    Auckland
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K153513

    Owner / Operator

    Firm Name
    ARTHREX, INC.
    Operator Number
    1220287
    Address
    1370 CREEKSIDE BLVD., --
    City
    Naples
    State
    FL
    Postal Code
    34108
    Country
    US
    Correspondent
    Barry Dietz

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Insufflator, Laparoscopic HIF
    Insufflator, Endoscopic Vessel Harvesting OSV

    Proprietary Names

    Insufflator 50L FM134

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device