BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MPF SHELL REVISION 68/52

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    50
    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
    K022120

    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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    MPF SHELL REVISION 68/52 MPF SHELL TRIO 52/41 MPF SHELL REVISION 60/48 MPF SHELL STANDARD 48/39 MPF PE INSERT HOODED 52/32 MPF PE INSERT HOODED 44/32 MPF SHELL REVISION 54/44 MPF PE INSERT STANDARD 52/32 MPF SHELL REVISION 52/41 MPF PE INSERT STANDARD 41/28 MPF SHELL REVISION 48/39 MPF PE INSERT HOODED 48/28 MPF SHELL TRIO 48/39 MPF PE INSERT STANDARD 52/28 MPF SHELL STANDARD 52/41 MPF SHELL STANDARD 54/44 MPF SHELL STANDARD 58/48 MPF SHELL TRIO 56/44 MPF SHELL TRIO 50/41 MPF PE INSERT HOODED 44/28 MPF PE INSERT STANDARD 44/28 MPF SHELL STANDARD 56/44 MPF PE INSERT HOODED 52/28 MPF SHELL TRIO 54/44 MPF PE INSERT STANDARD 44/32 MPF SHELL REVISION 50/41 MPF SHELL TRIO 64/48 MPF SHELL STANDARD 64/48 MPF SHELL STANDARD 50/41 MPF SHELL TRIO 62/48 MPF SHELL STANDARD 46/39 MPF SHELL REVISION 56/44 MPF SHELL STANDARD 62/48 MPF PE INSERT STANDARD 39/28 MPF SHELL REVISION 64/48 MPF SHELL REVISION 70/52 MPF SHELL REVISION 72/52 MPF PE INSERT STANDARD 48/32 MPF SHELL REVISION 62/48 MPF PE INSERT STANDARD 48/28 MPF SHELL TRIO 58/48 MPF PE INSERT HOODED 48/32 MPF PE INSERT HOODED 41/28 MPF SHELL TRIO 60/48 MPF SHELL REVISION 46/39 MPF SHELL TRIO 46/39 MPF SHELL STANDARD 60/48 MPF PE INSERT HOODED 39/28 MPF SHELL REVISION 66/52 MPF SHELL REVISION 58/48

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)