BEUDAMED
    FDA Registration Active 🇪🇨 Ecuador

    Stapler Cannula Blunt Obturator, Long

    Reg #: 3014635169 · FEI: 3014635169 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALEM
    Registration Number
    3014635169
    FEI Number
    3014635169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Vicente Duque N77-57, y Antonio Castillo
    City
    Quito Pichincha
    Country
    EC

    Regulatory Submissions

    510(k) Number
    K140553

    Owner / Operator

    Firm Name
    Intuitive Surgical, Inc.
    Operator Number
    9028901
    Address
    1266 Kifer Road, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Staple, Implantable GDW

    Proprietary Names

    Stapler Cannula Blunt Obturator, Long Stapler Cannula Blunt Obturator Stapler Cannula Stapler Sheath Stapler 45 Reload, Blue Stapler 45 Reload, Green Stapler 45 Reload, White 10-12mm+Stapler Cannula Seal EndoWrist® Stapler 45 Stapler-8mm Cannula Reducer Stapler Cannula, Long Stapler Release Kit EndoWrist® Stapler 45 Curved-Tip EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm EndoWrist Stapler Cannula Kit EndoWrist Stapler System Starter Kit - 45 mm SRK,ENGLISH,IS4000

    Establishment Types

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