BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD)

    Reg #: 1527821 · FEI: 1527821 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERIS CORPORATION
    Registration Number
    1527821
    FEI Number
    1527821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173256

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10078069
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Sterilant, Medical Devices MED

    Proprietary Names

    SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility