BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VBS

    Reg #: 1721676 · FEI: 1721676 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1721676
    FEI Number
    1721676
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5725 Harold Gatty Dr
    City
    Salt Lake City
    State
    UT
    ZIP
    84116
    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)