BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ambu10292 (GP) - aScope 4 Broncho Large 5.8/2.8 Ambu aScope 4 Broncho Regular 5/2.2 Ambu aScope 4 Broncho Slim 3.8/1.2

    Reg #: 1650907 · FEI: 3002681132 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    1650907
    FEI Number
    3002681132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1175 Isuzu Pkwy
    City
    GRAND PRAIRIE
    State
    TX
    ZIP
    75050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173727

    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
    Bronchoscope (Flexible Or Rigid) EOQ

    Proprietary Names

    Ambu10292 (GP) - aScope 4 Broncho Large 5.8/2.8 Ambu aScope 4 Broncho Regular 5/2.2 Ambu aScope 4 Broncho Slim 3.8/1.2

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)