BEUDAMED
    FDA Registration Active 🇺🇸 United States

    T169

    Reg #: 1061124 · FEI: 1000512168 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    52
    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
    K902319

    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
    Biopsy Needle FCG

    Proprietary Names

    T169 CT2020 T226 T186 T1815 T1411 T166 T1615 CT1820 T2015 CT2011 ACT2015 ACT1415 ACT2011 CT2015 T229 T2011 T1611 T149 ACT1820 ACT1815 T1820 ACT1811 T2020 T1915 T189 ACT2020 T1415 T206 ACT2215 CT2220 T1811 CT2215 T2215 T146 T209 CT1811 ACT2211 CT1815 T1620 T1420 TT1611 TT1620 TT1420 TT1411 TT1811 TT1415 TT1815 TT1615 TT166 TT186 TT1820

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)