BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Xi Conductive Reducer - 470381

    Reg #: 9616517 · FEI: 3003117688 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    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
    K140553

    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
    Staple, Implantable GDW
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    Xi Conductive Reducer - 470381 Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09) Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07) Xi Stapler 45 Reload (Blue) - 48645B Si Stapler Sheath - 410370 Xi Stapler 45 Reload (White) - 48645W Xi Stapler 45 Reload (Green) - 48445G Xi Seal (12mm & Stapler) - 470380 12 mm & Stapler Cannula Seal - 470380

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)