BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PLUS EPF FIT PE Hooded INSRT 8 DEG 66/28

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    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
    K994146

    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 EPF FIT PE Hooded INSRT 8 DEG 66/28 PLUS EPF FIT PE Hooded INSRT 8 DEG 54/28 PLUS EPF FIT PE INSRT 60/22 PLUS EPF FIT PE Hooded INSRT 8 DEG 62/28 PLUS EPF Titanium Shell Ti.Plasma 58 PLUS EPF FIT PE INSRT 46/22 PLUS EPF FIT PE Hooded INSRT 8 DEG 60/28 PLUS EPF Titanium Shell Ti.Plasma 66 PLUS EPF FIT PE INSRT 58/22 PLUS EPF Titanium Shell Ti.Plasma 40 PLUS EPF FIT PE INSRT 48/22 PLUS EPF FIT PE INSRT 60/28 PLUS EPF FIT PE Hooded INSRT 8 DEG 56/28 PLUS EPF FIT PE Hooded INSRT 8 DEG 68/28 PLUS EPF FIT PE INSRT 52/22 PLUS EPF FIT PE Hooded INSRT 8 DEG 50/28 PLUS EPF Titanium Shell Ti.Plasma 48 PLUS EPF Titanium Shell Ti.Plasma 56 PLUS EPF FIT PE Hooded INSRT 15DEG 66/28 PLUS EPF FIT PE INSRT 64/22 PLUS EPF FIT PE INSRT 50/22 PLUS EPF FIT PE Hooded INSRT 8 DEG 64/28 PLUS EPF FIT PE INSRT 44/22 PLUS EPF FIT PE INSRT 54/22 PLUS EPF FIT PE Hooded INSRT 8 DEG 52/28 PLUS EPF FIT PE INSRT 56/22 PLUS EPF Titanium Shell Ti.Plasma 60 PLUS EPF Titanium Shell Ti.Plasma 62 PLUS EPF Titanium Shell Ti.Plasma 44 PLUS EPF Titanium Shell Ti.Plasma 64 PLUS EPF Titanium Shell Ti.Plasma 50 PLUS EPF FIT PE Hooded INSRT 15DEG 68/28 PLUS EPF Titanium Shell Ti.Plasma 42 PLUS EPF Titanium Shell Ti.Plasma 46 PLUS EPF Titanium Shell Ti.Plasma 68 PLUS EPF FIT PE Hooded INSRT 8 DEG 58/28 PLUS EPF Titanium Shell Ti.Plasma 54 PLUS EPF FIT PE INSRT 62/22 PLUS EPF Titanium Shell Ti.Plasma 52 PLUS EPF FIT PE Hooded INSRT 8 DEG 48/28 PLUS EPF FIT PE Hooded INSRT 8 DEG 46/28

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)