BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROMOS REVERSE PE INSERT DIA36/12

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    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
    K081016

    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
    Shoulder Prosthesis, Reverse Configuration PHX

    Proprietary Names

    PROMOS REVERSE PE INSERT DIA36/12 PROMOS REV GLEN.BONE SCREW DIA6/40 PROMOS HUMERAL STEM 3.5 NON-CEM PROMOS REVERSE PE INSERT DIA36/6 PROMOS REV GLEN.BONE SCREW DIA6/30 PROMOS HUMERAL STEM 4 NON-CEM PROMOS REVERSE BODY DIA36/15MM NON-CEM PROMOS REV GLENOID BASE PLATE NON-CEM PROMOS REV GLEN.BONE SCREW DIA6/35 PROMOS REVERSE PE INSERT DIA42/12 PROMOS HUMERAL STEM 01 NON-CEM PROMOS REVERSE GLENOSPHERE CENTRIC DIA36 PROMOS REVERSE GLENOSPHERE CENTRIC DIA42 PROMOS REVERSE PE INSERT DIA36/9 PROMOS REVERSE BODY DIA36/10MM NON-CEM PROMOS REVERSE GLENOSPHERE ECCEN. DIA36/ PROMOS HUMERAL STEM 3 NON-CEM PROMOS REV GLEN.BONE SCREW DIA6/25 PROMOS REVERSE PE INSERT DIA42/6 PROMOS REVERSE BODY DIA42/15MM NON-CEM PROMOS REVERSE BODY DIA36/5MM NON-CEM PROMOS HUMERAL STEM 1.5 NON-CEM PROMOS HUMERAL STEM 2 NON-CEM PROMOS HUMERAL STEM 0 NON-CEM PROMOS REVERSE BODY DIA42/5MM NON-CEM PROMOS REVERSE BODY DIA42/10MM NON-CEM PROMOS HUMERAL STEM 1 NON-CEM PROMOS REV GLEN.BONE SCREW DIA6/20 PROMOS REVERSE GLENOSPHERE ECCEN. DIA42/ PROMOS REVERSE PE INSERT DIA42/9

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)