CE FDA 510K Approval No Air Leakage and 100% Leak-Proofness Disposable Optical Trocars for Laparoscopic Choledocholithotomy
Guangzhou T.K Medical Instrument Co., Ltd.- Material：Plastic
- Ethylene Oxide Sterilization：Ethylene Oxide Sterilization
- Quality Guarantee Period：3 Years
- Group：Laparoscopic Surgery
- Specification：10mm with 100mm length
- Trademark：TK
Base Info
- Model NO.：T05-100-CT-DF
- Origin：China
- HS Code：9018909000
- Production Capacity：100000
Description
Overview
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Packaging & Shipping Certifications
FDA 510K Approval
FAQ| 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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