BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TC PRIM/TC REV TIB INS TC CS ULTRAC 6/13

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3002907620
    FEI Number
    3002907620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1700 College Blvd.
    City
    West Memphis
    State
    AR
    ZIP
    72301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K000666

    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
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    TC PRIM/TC REV TIB INS TC CS ULTRAC 6/13 TC PRIM/TC REV TIB INS TC CS ULTRAC 6/11 TC PRIM TIBIAL INSERT TC CS ULTRAC 12/11 TC PRIM/TC REV TIB INS TC CS ULTRAC 4/13 TC PRIM/TC REV TIB INS TC CS ULTRAC 4/11 PLUS Mod Rev STEM Modul Dist w.Dist lock TC PRIM TIBIAL INSERT TC CS ULTRAC 12/19 PLUSTC PS Solu Tibl INSRT PS 6.17MM PLUSTC PS Solu Tibl INSRT PS 4.17MM TC PRIM/TC REV TIB INS TC CS ULTRAC 4/9 TC PRIM/TC REV TIB INS TC CS ULTRAC 6/9 TC PRIM/TC REV TIB INS TC CS ULTRAC 8/11 TC PRIM/TC REV TIB INS TC CS ULTRAC10/15 TC PRIM/TC REV TIB INS TC CS ULTRAC 2/19 TC PRIM/TC REV TIB INS TC CS ULTRAC 2/11 TC PRIM TIBIAL INSERT TC CS ULTRAC 12/15 TC PRIM TIBIAL INSERT TC CS ULTRAC 12/9 TC PRIM/TC REV TIB INS TC CS ULTRAC10/13 TC PRIM/TC REV TIB INS TC CS ULTRAC 4/19 TC PRIM/TC REV TIB INS TC CS ULTRAC 6/15 TC PRIM/TC REV TIB INS TC CS ULTRAC 2/9 TC PRIM/TC REV TIB INS TC CS ULTRAC 8/13 TC PRIM/TC REV TIB INS TC CS ULTRAC 8/15 TC PRIM/TC REV TIB INS TC CS ULTRAC 2/15 TC PRIM/TC REV TIB INS TC CS ULTRAC10/19 TC PRIM TIBIAL INSERT TC CS ULTRAC 12/13 TC PRIM/TC REV TIB INS TC CS ULTRAC 2/17 TC PRIM/TC REV TIB INS TC CS ULTRAC 6/19 TC PRIM/TC REV TIB INS TC CS ULTRAC10/11 PLUSTC PS Solu Tibl INSRT PS 2.17MM TC PRIM/TC REV TIB INS TC CS ULTRAC 4/15 TC PRIM/TC REV TIB INS TC CS ULTRAC 8/19 TC PRIM/TC REV TIB INS TC CS ULTRAC 10/9 TC PRIM/TC REV TIB INS TC CS ULTRAC 2/13 TC PRIM/TC REV TIB INS TC CS ULTRAC 8/9

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)