BEUDAMED
    FDA Registration Active 🇺🇸 United States

    282.290S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    82
    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
    K981757

    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
    Device, Fixation, Proximal Femoral, Implant JDO

    Proprietary Names

    282.290S 282.285S 282.308S 282.355S 282.276S 282.238S 282.265S 282.268S 282.310S 282.240S 282.255S 282.296S 282.272S 282.345S 282.354S 282.334S 282.246S 282.294S 282.336S 282.383S 282.235S 282.243S 282.306S 282.384S 282.324S 282.365S 282.356S 282.236S 282.254S 282.386S 282.247S 282.323S 282.346S 282.316S 282.274S 282.292S 282.338S 282.302S 282.344S 282.262S 282.241S 282.256S 282.373S 282.322S 282.234S 282.245S 282.328S 282.249S 282.363S 282.376S 282.284S 282.248S 282.270S 282.326S 282.266S 282.286S 282.374S 282.305S 282.244S 282.264S 282.312S 282.330S 282.278S 282.239S 282.366S 282.242S 282.340S 282.283S 282.375S 282.325S 282.288S 282.280S 282.385S 282.282S 282.237S 282.304S 282.263S 282.332S 282.364S 282.353S 282.303S 282.314S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)