BEUDAMED
    FDA Registration Active 🇺🇸 United States

    040878S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    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
    K051678

    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
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    040878S 0408.310S 040801S 0408.260S 0405.693S 0408.266S 0408.278S 0408.316S 0408.360S 0408.228S 0405.692S 0408.366S 0408.328S 0405.695S 0408.210S 0405.691S 0408.216S 040828S 040866S 040816S 0405.694S 0408.378S 040810S 040860S 040800S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)