BEUDAMED
    FDA Registration Active 🇺🇸 United States

    04.11285S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    60
    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
    K111540

    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

    04.11285S 04.11292S 04.11231S 04.11293S 04.11294S 02.11208S 02.11230S 02.11226S 04.11229S 04.11283S 02.11213S 02.11210S 02.11211S 04.11227S 04.11226S 04.11281S 04.11210S 04.11206S 04.11230S 02.11212S 02.11282S 02.11283S 04.11282S 02.11281S 04.11219S 02.11227S 04.11228S 02.11207S 02.11293S 04.11280S 02.11280S 02.11206S 02.11218S 02.11221S 04.11290S 04.11209S 02.11284S 02.11285S 04.11213S 02.11294S 04.11284S 04.11291S 02.11295S 02.11228S 04.11218S 02.11292S 02.11290S 04.11295S 02.11219S 02.11209S 04.11220S 02.11220S 04.11211S 04.11208S 04.11212S 02.11229S 02.11231S 04.11221S 04.11207S 02.11291S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)