BEUDAMED
    FDA Registration Active 🇺🇸 United States

    44173S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    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
    K061753

    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

    Proprietary Names

    44173S 44176S 44196S 44177S 441.107S 44174S 24177S 441.106S 44197S 241.104S 24175S 24194S 44183S 44172S 24197S 24183S 24182S 24174S 241.105S 44184S 441.104S 24187S 241.106S 241.107S 24196S 44194S 44186S 441.105S 44182S 24176S 24195S 44185S 44187S 24173S 24185S 44195S 24172S 24184S 44175S 24186S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)