BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    4K UHD Laparoscope

    DI: 06971381252149 · Model: 4K5545L · Scivita Medical Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    4K UHD Laparoscope
    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
    5
    Public Version Date
    2025-06-26
    Public Version Status
    Update
    Public Device Record Key
    45ed8402-ec7e-4416-856c-58712f831d06

    Device Description

    Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, 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 visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Hydrogen Peroxide, High-level Disinfectant, 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
    70 – 106 KiloPascal
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    20 – 80 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    5 – 40 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    20 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 55 Degrees Celsius