BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xi Optical Obturator (12mm & Stapler, Long), (470404-01 & -02)

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152663

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Xi Optical Obturator (12mm & Stapler, Long), (470404-01 & -02) Xi Optical Obturator (8mm, Long), (470360-01 &-02) Xi Optical Obturator (12mm & Stapler, Standard), (470403-01 &-02) Xi Optical Obturator (8mm, Standard), (470359-01 &-02) Xi Optical Obturator (12mm & Stapler, Long) -470404 Xi Optical Obturator (8mm, Long) - 470360 8 mm Bladeless Obturator - 470359 Xi Optical Obturator (12mm & Stapler, Standard) - 470403 Xi Optical Obturator (8mm, Standard) - 470359 8 mm Bladeless Obturator, Long - 470360

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)