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    FDA UDI In Commercial Distribution 🇺🇸 United States

    cortiQ PRO

    DI: EBCI80600 · Model: TD 1.x · g.tec medical engineering GmbH
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    cortiQ PRO
    Primary DI
    EBCI80600
    Version / Model
    TD 1.x
    Company Name
    g.tec medical engineering GmbH
    Labeler DUNS
    300916041
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-06
    Public Version
    3
    Public Version Date
    2021-05-06
    Public Version Status
    Update
    Public Device Record Key
    18d244af-e47c-4f55-88e6-9d4bd5e52aa2

    Device Description

    cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLU Normalizing Quantitative Electroencephalograph Software
    GWL Amplifier, Physiological Signal
    OLT Non-Normalizing Quantitative Electroencephalograph Software

    GMDN Terms

    Code Name
    35777 Electroencephalographic spectrum analyser

    Identifiers

    Type ID
    Primary EBCI80600

    Customer Contacts

    Phone
    +437251222400
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K191432 000