BEUDAMED
    FDA Registration Active 🇺🇸 United States

    0606-515-000

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    65
    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
    Mixer, Cement, For Clinical Use JDZ

    Proprietary Names

    0606-515-000 0506-686-015 0606-520-000 0606-509-000 0306-563-000 0506-483-000 0506-689-015 General Surgical Instrument KYPHON® Mixer MIXOR FEMORAL PRESSURIZER-LG VORTEX&MIXOR NZLE LONG TAPERED VORTEX & MIXOR NOZZLE ANGLED VORTEX&MIXOR NZLE STAND BRKAWY VORTEX ADAPTER ER2 Saturate Mixing System VORTEX VACUUM BOWL VORTEX VACUUM MIXING SYSTEM VORTEX & MIXOR NOZZLE REVISION VORTEX & MIXOR NOZZLE UMBRELLA 0206-556-000 0206-545-000 VORTEX RE-USE KIT VACUUM TUBE W/SUC BYPASS 0206-546-000 0206-547-000 0206-548-000 0206-566-000 0206-509-000;0206-564-000 0506-683-015 0506-682-015 0606-514-000 0606-593-000S1 0605-687-015 0605-887-000 0506-482-000 Medium Port MiniMix Bone Cement Mixing System SMMM1 Mixing Bowl, Spatula B710 0606-595-000 0606-593-000 0606-563-000 0506-489-000 0606-553-000S1 0606-705-000S1 0606-516-000 0506-486-000 0606-517-000 RALLY Vacuum Mixing Bowl 7127-1801 0606-705-000 0606-573-000 0606-583-000 0605-683-015 0506-485-000 Kyphon Mixer 0306-564-000 0606-565-000 0605-685-015 0306-573-000 0506-687-015 0506-685-015 0606-512-000 HiVac Bowl Bone Cement Mixing System B713 0606-518-000 0606-553-000 MiniMix LV Bone Cement Mixing System SMLV 0306-553-000S2

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)