BEUDAMED
    FDA Registration Active 🇺🇸 United States

    457.125S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    36
    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
    K932593

    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

    457.125S 45610S 456.100S 45710S 456.80S 45611S 456.110S 45790S 45613S 457.100S 457.211S 45913S 45775S 456.105S 45712S 45912S 45711S 456.120S 45612S 456.90S 45780S 456.85S 45770S 457.110S 45914S 456.70S 457.210S 457.115S 456.95S 456.115S 457.105S 45785S 457.120S 457.212S 456.75S 45795S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)