BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CA1820

    Reg #: 1061124 · FEI: 1000512168 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1061124
    FEI Number
    1000512168
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10821 Withers Cove Park Dr
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141552

    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
    Instrument, Biopsy KNW

    Proprietary Names

    CA1820 A186 BCA1215 A206 CA2011 CA2020 CA2015 A2015 BA149 BA129 BA1411 A146 BCA1211 A1811 A189 A1411 A149 BA1215 A1420 A1611 A1415 A1820 CA1811 A1825 CA1615 A209 CA1420 BA1211 A1615 A2011 CA1411 A169 CA1611 A1815 CA1415 A1620 A2020 CA1620 BCA1411 CA1815 A166

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)