BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTRODIGITATOR

    Reg #: 3009504230 · FEI: 3009504230 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Radiation Technologies IN, Inc
    Registration Number
    3009504230
    FEI Number
    3009504230
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4394 East Park 30 Drive
    City
    Columbia City
    State
    IN
    ZIP
    46725
    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
    Dispenser, Cement KIH

    Proprietary Names

    INTRODIGITATOR 90 Degree Breakaway Nozzle CDrive Cement Dispenser CDrive Cartridge Assembly KYPHON® Directional Bone Filler Device JET-VAC CEM DISP INT TIP KYPHON® Cement Delivery System Kyphon Cement Delivery System Kyphon Bone Filler Devices Kyphon Bone Filler Device FEMORAL PRESSURIZER Cement dispenser KYPHON® Bone Filler Devices MiniMix Delivery Syringe SMDS1C HiVac Syringe Bone Cement Mixing and Delivery System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)