BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intuitive_5779 (SDA,GP) - Stapler SureForm™ 45 Curved-Tip

    Reg #: 2032112 · FEI: 3003076831 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    2032112
    FEI Number
    3003076831
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7685 ST.ANDREWS AVE.
    City
    SAN DIEGO
    State
    CA
    ZIP
    92154
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222839

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

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

    Proprietary Names

    Intuitive_5779 (SDA,GP) - Stapler SureForm™ 45 Curved-Tip Intuitive_5779 (SDA,GP) - Stapler SureForm™ 45 Straight-Tip Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 45 (Grey) Intuitive_5779 (SDA,GP) - Stapler SureForm™ 60 Instrument Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 45 Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 60 Intuitive_5779 (SDA,GP) - Xi Stapler 30 Reload

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)