BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ThoraTrak Model, 28604B, Blade Long Extended Mount Standard 16L

    Reg #: 3003661577 · FEI: 3003661577 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KLUGE DESIGN INC.
    Registration Number
    3003661577
    FEI Number
    3003661577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14150 Northdale Blvd
    City
    Rogers
    State
    MN
    ZIP
    55374
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132645

    Owner / Operator

    Firm Name
    Kluge Design LLC
    Operator Number
    10030771
    Address
    14150 Northdale Blvd
    City
    Rogers
    State
    MN
    Postal Code
    55374
    Country
    US
    Correspondent
    Erik Kariniemi

    Products

    Device Name Product Code
    Retractor GAD

    Proprietary Names

    ThoraTrak Model, 28604B, Blade Long Extended Mount Standard 16L ThoraTrak Model 28605, Blade Short Thoracotomy Standard 16L ThoraTrak Model 28602, Blade LIMA Deep 16L KIT THT-JPSTD THORATRAK JP Standard Set KIT THT-WWSTD THORATRAK Full System Set ThoraTrak Model 28610, Retractor System ThoraTrak Model 28611, Retractor Rack ThoraTrak Model 28606, Blade Short Thoracotomy Deep 16L ThoraTrak Model 28604, Blade Long Thoracotomy Deep 16L ThoraTrak Model 28606B, Blade Short Extended Mount Standard 16L ThoraTrak Model 28601, Blade LIMA Standard 16L ThoraTrak Model 28603, Blade Long Thoracotomy Standard 16L

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)