BEUDAMED
    FDA Registration Active 🇺🇸 United States

    421.302S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    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
    K031761

    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
    Plate, Bone JEY

    Proprietary Names

    421.302S 421.304S 42145S 420.45S 420.403S 42149S 446.44S 420.402S 42140S 42144S 420.303S 420.44S 42148S 446.45S 420.302S 420.40S 446.40S 421.303S 420.401S 42143S 420.304S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)