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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Scivita 4KINSIGHT ICG imaging system

    DI: 06971381252149 · Model: 4K5545L · SCIVITA MEDICAL TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Scivita 4KINSIGHT ICG imaging system
    Primary DI
    06971381252149
    Version / Model
    4K5545L
    Company Name
    SCIVITA MEDICAL TECHNOLOGY CO., LTD.
    Labeler DUNS
    544519831
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-19
    Public Version
    1
    Public Version Date
    2023-05-29
    Public Version Status
    New
    Public Device Record Key
    45ed8402-ec7e-4416-856c-58712f831d06

    Device Description

    The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraop erative cholangiography. The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and near infrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive s urgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for bil iary duct visualization. Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessel s and lymph nodes.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery
    IZI System, X-Ray, Angiographic

    GMDN Terms

    Code Name
    12291 Rigid optical laparoscope

    Identifiers

    Type ID
    Primary 06971381252149
    Package 16971381252146

    Premarket Submissions

    Submission Number Supplement Number
    K221252 000

    Storage Conditions

    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    700 – 1060 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    20 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 55 Degrees Celsius