BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PLUS FIT Titanium Shell 40

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    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
    K973077

    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/Polymer, Uncemented LWJ

    Proprietary Names

    PLUS FIT Titanium Shell 40 PLUS FIT Titanium Shell 64 PLUS FIT Titanium Shell 52 PLUS FIT Titanium Shell 54 PLUS FIT Titanium Shell 66 PLUS FIT Titanium Shell 58 PLUS FIT Titanium Shell 68 PLUS FIT Titanium Shell 56 PLUS FIT Titanium Shell 62 PLUS FIT Titanium Shell 48 PLUS FIT Titanium Shell 42 PLUS FIT Titanium Shell 60 PLUS FIT Titanium Shell 46 PLUS FIT Titanium Shell 44

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)