Health & Medicine

    Single Use Bladed Trocar 10mm Surgical Instruments

    Guangzhou T.K Medical Instrument Co., Ltd.
    • Type:Surgical Supplies Materials
    • Material:Plastic
    • Ethylene Oxide Sterilization:Ethylene Oxide Sterilization
    • Quality Guarantee Period:3 Years
    • Group:Laparoscopic Surgery
    • Logo Printing:With Logo Printing

    Base Info

    • Model NO.:T10-100-CT-A
    • Transport Package:Package
    • Specification:10mm with 100mm length
    • Trademark:TK
    • Origin:China
    • HS Code:9018909000
    • Production Capacity:100000

    Description

    Overview Detailed PhotosProduct Parameters

     

    Company Profile

    Single Use Bladed Trocar 10mm Surgical Instruments


    Single Use Bladed Trocar 10mm Surgical Instruments




     Packaging & Shipping Certifications

    FDA 510K Approval

    Single Use Bladed Trocar 10mm Surgical Instruments
    FDA 510K Letter: K193272

    Trade/Device Name: GTK Trocars

    Regulation Number: 21 CFR 876.1500

    Date: July 6, 2020

    CE certificate

    Single Use Bladed Trocar 10mm Surgical InstrumentsRegistration No.: HD 60147623 0001


    Report No.: 17025753 014


    Effective Date: July 24, 2020



      
    Trocars
    Q: Are you a factory or trading company?
    A: Yes. We are a factory in China with 17 years surgical devices developing and manufacturing experience.
    Q: What is the core strength of GTK Medical?
    A: Our core strength is strong R&D Capability (more than 600 patents applied) and world first class quality (FDA 510K, CE, ISO13485:2016) management on products.
    Q: What makes GTK Trocars stand out?
    A:  Excellent sealing performance plus excellent smooth insertion and removal of surgical instruments.
    Q: Do you provide free samples of GTK Trocars for clinical trial use?
    A: Yes. We are proud and confident to provide free samples for real clinical testing and evaluation.
    Q: Do you have exported experiences to large medical devices company/companies?
    A: Yes. We exported to more than 40 countries, most of which are based in the America and Europe.
    Q: Do you accept factory audit prior to formal partnership?
    A: Yes. We are proud and confident to accept factory audit. We passed US FDA on site aduits on 2015 and 2021. 

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