Gtk Bladed Trocar Laparoscopic Trocar FDA 510K Cleared Top 3 China Factory Manufacturer
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Product Details
| Customization: | Available |
|---|---|
| Type: | Abdominal Access |
| Material: | Plastic |
Diamond Member Since 2021
Suppliers with verified business licenses
Audited Supplier Audited by an independent third-party inspection agency
Year of Establishment
2004-03-03
Number of Employees
138
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Basic Info.
- Model NO.
- T12-100-CT-A
- Ethylene Oxide Sterilization
- Ethylene Oxide Sterilization
- Quality Guarantee Period
- 3 Years
- Group
- Laparoscopic Surgery
- Logo Printing
- With Logo Printing
- Sterilization
- Eo
- Shelf Life
- 3 Years
- Certificates
- CE, FDA 510K
- Quality System
- ISO 13485:2016
- Color
- Transparent Blue
- Export Experience
- More Than 15 Years
- Transport Package
- Blister Package and Carton Packing
- Specification
- 10mm with 100mm length
- Trademark
- TK
- Origin
- China
- HS Code
- 9018909000
- Production Capacity
- 100000
Product Description
G T.K trocars have been exported to 40 countries, most of which are European and American countries, such as the USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.
FDA 510K Letter: K193272
Trade/Device Name: GTK Trocars
Regulation Number: 21 CFR 876.1500
Date: July 6, 2020
Please do not hesitate to contact me right now to get best quotation~
GTK disposable optical tip trocars Characteristic
| Universality: | No need to have an adapter between 5mm and 15mm laparoscopic surgical 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. |
| Universality | No need to have an adapter between 5mm and 12mm instruments. It is compatible to all kinds of surgical instruments. |
| Leak-proofness: | The universal seal can be replaced without removing the trocar cannula, ensuring 100% leak-proofness. |
| Pleasing Design | Pattern and color design is pleasing and comfortable to eyes. |
| Detachability | The sealing components can be detached to remove large tissue or organ. |
| Reliability | 21 inspection steps on each trocar ensures high quality. |
| Trocars (CT-DF) | |||
| Specification | |||
| Product Code | Number of Cannula | Diameter (mm) | Working Length (mm) |
| T05-75-CT-DF | 1 pc 5mm | 5 | 75 |
| T12-75-CT-DF | 1 pc 12mm | 12 | 75 |
| T05-100-CT-DF | 1 pc 5mm | 5 | 100 |
| T10-100-CT-DF | 1 pc 10mm | 10 | 100 |
| T12-100-CT-DF | 1 pc 12mm | 12 | 100 |
| T05-150-CT-DF | 1 pc 5mm | 5 | 150 |
| T10-150-CT-DF | 1 pc 10mm | 10 | 150 |
| T12-150-CT-DF | 1 pc 12mm | 12 | 150 |
| 2T052-CT-DF | 2 pcs 5mm | 5 | 100 |
| 2T102-CT-DF | 2 pcs 10mm | 10 | 100 |
| 2T122-CT-DF | 2 pcs 12mm | 12 | 100 |
| 3T52101-CT-DF | 2 pcs 5mm & 1 pc 10mm | 5 & 10 | 100 |
| 4T52102-CT-DF | 2 pcs 5mm & 2 pcs 10mm | 5 & 10 | 100 |
| 5T521021-CT-F | 2 pcs 5mm & 2 pcs 10mm | 5 & 10 | 100 |
G T.K Medical is a hi-tech company which focuses on the research, development, manufacturing and marketing of medical devices for more than 18 yeras.
G T.K trocars have been exported to 40 countries, most of which are European and American countries, such as the USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.
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
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. |
Please do not hesitate to contact me right now to get best quotation~
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