Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared

Product Details
Customization: Available
Type: Medical Devices
Material: Metal, Plastic
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Manufacturer/Factory & Trading Company

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Audited Supplier

Audited by an independent third-party inspection agency

Number of Employees
138
Year of Establishment
2004-03-03
  • Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared
  • Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared
  • Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared
  • Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared
  • Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared
  • Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared
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  • Overview
  • Company Profile
  • Product Description
  • Product Parameters
  • Certifications
  • FAQ
Overview

Basic Info.

Model NO.
T05-100-A
Ethylene Oxide Sterilization
Ethylene Oxide Sterilization
Quality Guarantee Period
Three Years
Group
Laparoscopic Surgery Patients
Transport Package
Blister Box Packaging
Trademark
TK
Origin
China
HS Code
9018909000
Production Capacity
100000

Product Description

G T.K bladed tip trocars are safe, 100% leak-proofness, compatible to all kinds of surgical instruments.

Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared
Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared

 

Company Profile

We have specialized in medical devices and laparoscopic instruments field for over 17 years. Our products have been sold to more than 1000 top-rank hospitals in China. Our annual sales volume for trocars and retriever bags exceeds 100,000 units.

We export trocars, retriever bags and veress needles to 40 countries, most of which are European and American countries, such as the USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.

We offer full range and high-quality products--We were on-site audited by FDA from 1/3/2015 to 1/13/2015, and from 7/5/2021 to 16/5/2021. We passed FDA audit and have established stable contact relationship with FDA auditors.

We have FDA Registration, CE Certificate, ISO13485:2016 Certificate, Free Sale Certificate, and Declaration of Conformity for all our products including retriever bags, trocars, veress needles.

Minimally Invasive Surgery Medical Disposable Trocar FDA ClearedMinimally Invasive Surgery Medical Disposable Trocar FDA ClearedMinimally Invasive Surgery Medical Disposable Trocar FDA Cleared

Product Description
G T.K trocars are with special features as follows:
 
Universality: 
No need to have an adapter between 5mm and l5mm instruments. It is compatible to all kinds of surgical instruments.
 
Safety: 
The ergonomic design of the trocar thread not only makes instruments stable but also reduces harm to skin.
 
Leak-proofness:
The universal seal can be replaced without removing the trocar cannula, ensuring 100% leak-proofness.
 
Design: 
Pattern and color design is pleasing and comfortable to eyes.
 
Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared

 
Product Parameters
 
Trocars (A)      
Specification      
Product Code Number of Cannula Diameter (mm) Working Length (mm)
T05-100-A 1 pc 5mm 5 100
T10-100-A 1 pc 10mm 10 100
T12-100-A 1 pc 12mm 12 100
T10-100-A-10T 1 pc 10mm 10 100
T12-100-A-12T 1 pc 12mm 12 100

Certifications

Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared

 

FAQ

Minimally Invasive Surgery Medical Disposable Trocar FDA Cleared

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. 

Please do not hesitate to contact me, I am always here waiting for assisting you!
 

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