BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Xi Conductive Reducer - 470381

    Reg #: 9611665 · FEI: 3002807095 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics EO Canada, Inc.
    Registration Number
    9611665
    FEI Number
    3002807095
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    400 Ambassador Drive
    City
    Mississauga Ontario
    Country
    CA

    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)