BEUDAMED
    FDA Registration Active 🇺🇸 United States

    0606-515-000

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    65
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    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)