BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Thermedx7581 (PL) - Luer Lock Set, Single Lumen

    Reg #: 2246552 · FEI: 2246552 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    2246552
    FEI Number
    2246552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3459 SOUTH CLINTON AVE.
    City
    S Plainfield
    State
    NJ
    ZIP
    07080
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172048

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Warmer, Thermal, Infusion Fluid LGZ
    Insufflator, Hysteroscopic HIG
    Arthroscope HRX

    Proprietary Names

    Thermedx7581 (PL) - Luer Lock Set, Single Lumen Thermedx7581 (PL) - Urology Set Thermedx7581 (PL) - Tubing Set - Single Lumen, Inflow with Dual Outflow

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)