BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IRRAflow

    Reg #: 3013508628 · FEI: 3013508628 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    IRRAS USA, Inc
    Registration Number
    3013508628
    FEI Number
    3013508628
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10965 Via Frontera Drive
    City
    San Diego
    State
    CA
    ZIP
    92127
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171880

    Owner / Operator

    Firm Name
    IRRAS USA Inc.
    Operator Number
    10054623
    Address
    10965 Via Frontera Drive
    City
    San Diego
    State
    CA
    Postal Code
    92127
    Country
    US
    Correspondent
    Greg Cerra

    Products

    Device Name Product Code
    Shunt, Central Nervous System And Components JXG
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    IRRAflow

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198