BEUDAMED
    FDA Registration Active 🇺🇸 United States

    08.803.217S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    70
    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
    K072791

    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    08.803.217S 08.80351S 08.809.617S 08.803.115S 08.809.277S 08.809.257S 08.809.249S 08.803.131S 08.803.110S 08.809.651S 08.803.107S 08.803.235S 08.809.273S 08.803.208S 08.809.235S 08.809.213S 08.809.669S 08.809.657S 08.809.231S 08.809.275S 08.809.609S 08.809.255S 08.803.113S 08.803.230S 08.809.209S 08.809.637S 08.80353S 08.80350S 08.809.229S 08.809.237S 08.80352S 08.80355S 08.809.611S 08.809.211S 08.803.135S 08.809.633S 08.809.253S 08.809.613S 08.803.207S 08.809.675S 08.803.132S 08.809.233S 08.803.111S 08.809.269S 08.803.212S 08.803.213S 08.809.655S 08.803.211S 08.803.108S 08.803.112S 08.803.231S 08.809.629S 08.803.117S 08.809.649S 08.803.233S 08.809.217S 08.803.133S 08.803.209S 08.809.653S 08.809.635S 08.809.251S 08.809.677S 08.803.232S 08.809.673S 08.809.215S 08.803.109S 08.809.615S 08.809.631S 08.803.210S 08.803.215S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)