BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.112.149S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    2

    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
    K083213

    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, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    02.112.149S 02.112.136S 02.112.141S 02.112.140S 02.112.129S 02.112.148S 02.112.119S 02.112.118S 02.112.145S 02.112.138S 02.112.157S 02.112.139S 02.112.109S 02.112.106S 02.112.125S 02.112.126S 02.112.153S 02.112.142S 02.112.114S 02.112.107S 02.112.122S 02.112.117S 02.112.160S 02.112.108S 02.112.121S 02.112.144S 02.112.111S 02.112.113S 02.112.137S 02.112.143S 02.112.158S 02.112.123S 02.112.159S 02.112.115S 02.112.127S 02.112.131S 02.112.112S 02.112.152S 02.112.110S 02.112.156S 02.112.130S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)