BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Laproscopes

    Reg #: 3012470322 · FEI: 3012470322 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Arthrex Japan G.K. (Shinjuku)
    Registration Number
    3012470322
    FEI Number
    3012470322
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Shinjuku NS BLDG 28F, 2-4-1 Nishi-Shinjuku
    City
    Shinjuku-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K941541

    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 ext. 76939

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Laproscopes

    Establishment Types

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