BEUDAMED
    FDA Registration Active 🇺🇸 United States

    462.652S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    39
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K992348

    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
    Nail, Fixation, Bone JDS

    Proprietary Names

    462.652S 462.928S 462.636S 462.923S 462.931S 462.665S 462.634S 462.642S 462.726S 462.644S 462.646S 462.722S 462.932S 462.648S 462.640S 462.728S 462.666S 462.667S 462.927S 462.720S 462.729S 462.919S 462.929S 462.660S 462.723S 462.725S 462.926S 462.731S 462.727S 462.724S 462.732S 462.650S 462.922S 462.638S 462.654S 462.920S 462.925S 462.924S 462.719S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)