BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fiducial Holder

    Reg #: 1054811 · FEI: 1000114185 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S. LLC
    Registration Number
    1054811
    FEI Number
    1000114185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    502 Prairie Mine Rd
    City
    MULBERRY
    State
    FL
    ZIP
    33860
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032576

    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
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    Fiducial Holder Needle Block Holder Grid Mobilization Plate Needle Hub Assembly Pillar Immobilization Plate Grid Immobilization Plate LBS M-L Pillar Immobilization Plate LBS M-L Grid Immobilization Plate LBS C-C Pillar Immobilization Plate LBS C-C Pillar Immobilization Plate BBC

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)