BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dib UltraNav Transseptal Catheter System

    Reg #: 3027097031 · FEI: 3027097031 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DIB ULTRANAV MEDICAL, LLC
    Registration Number
    3027097031
    FEI Number
    3027097031
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    123 W. Mills Avenue, STE 600
    City
    El Paso
    State
    TX
    ZIP
    79901
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213492

    Owner / Operator

    Firm Name
    Dib UltraNav Medical, LLC
    Operator Number
    10087777
    Address
    123 W. Mills Avenue, STE 600
    City
    El Paso
    State
    TX
    Postal Code
    79901
    Country
    US
    Correspondent
    Noelle Sutton

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Dib UltraNav Transseptal Catheter System

    Establishment Types

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