Gtk Disposable Trocar High Standard Surgical Instruments Optical Trocar

• 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 ===

• 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

 Packaging & Shipping Certifications

FDA 510K Approval

FDA 510K Letter: K193272

Trade/Device Name: GTK Trocars

Regulation Number: 21 CFR 876.1500

Date: July 6, 2020

CE certificate

Registration 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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