BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VBS

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3004111573
    FEI Number
    3004111573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1302 Avenue T
    City
    Grand Prairie
    State
    TX
    ZIP
    75050
    Country
    US

    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
    Injector, Vertebroplasty (Does Not Contain Cement) OAR

    Proprietary Names

    VBS Delivery Syringe & Stopcock Master Syringe Assembly X-Change Cement Dispensing Syringe Hydraulic Assembly Hydraulic-Master Syringe Assembly Injector, Vertebroplasty (does not contain cement) 0306-134-000 0306-310-000 0306-080-000 0306-511-000 0306-150-000 0306-160-000 0306-531-000 0306-114-000 0306-140-000 CDAK008 Single use, sterile procedural tray/kit AVAtex Cement Delivery Accessory Kit 8G CDAK011 Single use, sterile procedural tray/kit AVAtex Cement Delivery Accessory Kit 11G 0306-081-000 0306-330-000 0306-331-000 0306-530-000 CDAK010 Single use, sterile procedural tray/kit AVAtex Cement Delivery Accessory Kit 10G

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)