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510K Cleared Disposable Sterile Trocars 3mm and 5mm Trocars for Pediatric Surgery

510K Cleared Disposable Sterile Trocars 3mm and 5mm Trocars for Pediatric Surgery

Overview 510K cleared disposable sterile trocars 5mm, 10mm, 12mm, 15mm trocars for abese patients,100% no air leakage, c
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Description

Overview
Basic Info.
Model NO. T05-55-CT-S
OEM Yes
MOQ 1
Color Blue
Transport Package Peel Pouch Packaging
Specification 5mm*55mm
Trademark TK
Origin China
HS Code 9018909000
Production Capacity 100000
Product Description

510K cleared disposable sterile trocars 5mm, 10mm, 12mm, 15mm trocars for abese patients,100% no air leakage, compatible to all kinds of surgical instruments.

510K Cleared Disposable Sterile Trocars 3mm and 5mm Trocars for Pediatric Surgery

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.

510K Cleared Disposable Sterile Trocars 3mm and 5mm Trocars for Pediatric Surgery

510K Cleared Disposable Sterile Trocars 3mm and 5mm Trocars for Pediatric Surgery

510K Cleared Disposable Sterile Trocars 3mm and 5mm Trocars for Pediatric Surgery

Product Description
G T.K trocars are with special features as follows:
Visible: An endoscope can be inserted into an optical trocar to make the whole surgery process
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.
Detachability: The sealing components can be detached to remove large tissue or organ.
Detailed Photos

510K Cleared Disposable Sterile Trocars 3mm and 5mm Trocars for Pediatric Surgery


Product Parameters
Trocars (CT-F)
Specification
Product CodeNumber of CannulaDiameter (mm)Working Length (mm)
T03-55-CT-S1 pc 3mm355
T05-55-CT-S1 pc 5mm555
T05-100-CT-S1 pc 5mm5100
T05-75-CT-F1 pc 5mm575
T12-75-CT-F1 pc 12mm1275
T05-100-CT-F1 pc 5mm5100
T10-100-CT-F1 pc 10mm10100
T12-100-CT-F1 pc 12mm12100
T05-150-CT-F1 pc 5mm5150
T10-150-CT-F1 pc 10mm10150
T12-150-CT-F1 pc 12mm12150
2T052-CT-F2 pcs 5mm5100
2T102-CT-F2 pcs 10mm10100
2T122-CT-F2 pcs 12mm12100
3T52101-CT-F2 pcs 5mm & 1 pc 10mm5 & 10100
4T52102-CT-F2 pcs 5mm & 2 pcs 10mm5 & 10100
4T52122-CT-F2 pcs 5mm & 2 pcs 12mm5 & 12100
CertificationsFAQ
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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