BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

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

    Reg #: 9616517 · FEI: 3003117688 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics S. de R.L. de C.V.
    Registration Number
    9616517
    FEI Number
    3003117688
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parque Industrial Tepeji, Calle North 7 s/n
    City
    Tepeji del Rio de Ocampos Hidalgo
    Country
    MX

    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)