BEUDAMED
    FDA Registration Active 🇺🇸 United States

    08.807.223S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    63
    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
    K103320

    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
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    08.807.223S 08.807.312S 08.807.311S 08.807.234S 08.807.323S 08.807.232S 08.807.2002S 08.807.334S 08.807.244S 08.807.308S 08.807.221S 08.807.241S 08.807.202S 08.807.222S 08.807.206S 08.807.224S 08.807.309S 08.807.236S 08.807.313S 08.807.322S 08.807.233S 08.807.315S 08.807.310S 08.807.207S 08.807.213S 08.807.211S 08.807.214S 08.807.335S 08.807.205S 08.807.341S 08.807.201S 08.807.307S 08.807.303S 08.807.209S 08.807.246S 08.807.3002S 08.807.304S 08.807.235S 08.807.343S 08.807.243S 08.807.344S 08.807.301S 08.807.215S 08.807.210S 08.807.203S 08.807.231S 08.807.333S 08.807.212S 08.807.332S 08.807.345S 08.807.321S 08.807.342S 08.807.245S 08.807.242S 08.807.331S 08.807.305S 08.807.208S 08.807.325S 08.807.302S 08.807.306S 08.807.324S 08.807.204S 08.807.314S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)