Disposable Surgical Hemostatic Clip Endoscopic Hemostatic Clip for Stanching Bleeding with 510K FDA
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Product Highlights
- FDA 510K Clearance: Product holds 510K FDA clearance for medical use.
- Reopening Capability: Can be repeatedly opened and closed at least five times for precise placement.
- Radiopaque Design: Visible under X-ray to ensure accurate positioning during surgery.
- Ergonomic Handle: Intuitive tactile feedback indicates when the gripper is ready to release.
- Wide Claw Distance: 16mm wide claw distance allows grasping of large tissue pieces.
- Ready-to-Use System: Integrated pre-assembled system ready for immediate application upon opening.
- Window & Hole Design: Secure clip design featuring window and hole for enhanced traction.
Product Attributes
- Customization
- Available
- Type
- Surgical Supplies Materials
- Material
- ABS
- Model NO.
- SD-02-165-13c
- Ethylene Oxide Sterilization
- Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Group
- Adult
- Logo Printing
- With Logo Printing
- Opening
- 13mm
- Length
- 165cm
- Coated Plastic
- Yes
- Channel
- 2.8mm
- Handle Type
- Rotatable
- Model
- SD-02-165-13c
- Transport Package
- Cartoon
- Specification
- 165CM
- Trademark
- Soudon
- Origin
- China
- HS Code
- 9018903090
- Production Capacity
- 10000000
Product Images of Disposable Surgical Hemostatic Clip Endoscopic Hemostatic Clip for Stanching Bleeding with 510K FDA
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Product Description
[Application]In medical institutions, this product is used in conjunction with endoscopes and high-frequency generators for the removal of polyps in the digestive tract.
detail picture
Clip length much shorter than other supplier's
Clip material NAS steel is imported from Japan
Integrated pre-assembled system, the product is ready to leave the factory, open the package can be applied, which is very beneficial for emergency hemostasis.
16mm wide claw distance is beneficial to grasp large pieces of tissue.
The ergonomic handle can intuitively perceive the opening and closing of the gripper. Once the gripper is closed, tactile feedback can be generated to indicate that it is ready to release.
| Part No. | Opening(mm) | Effective Length (cm) | Coated Plastic | Channel(mm) | Handle Type |
| SD-02-165-13C | 13 | 165 | YES | 2.8 | Rotatable |
Soudon service
OEM:your company logo or name,color,detail specification of product
Quality: As long as there is damage due to non-human reasons, we provide free replacement
Support: We will try our best to provide the documents needed by suppliers to support the cooperation
Instructions
1. First check whether the aseptic packaging of the product is intact, then take out the clip device, gently tighten the sliding handle, and pull out the head protection cap of the clip device.
2. Slightly tighten the slide handle to ensure the clips are closed. Carefully insert the clip device through the biopsy channel of the endoscope, 2-3 cm at a time.
3. When the clip device protrudes 2-3 cm from the front end of the endoscope channel and reaches the expected position, open the clip of the clip device: gently move the sliding handle to the far end (away from the thumb ring) until it encounters greater resistance And pause, now the clip is in the open state;
4. The rotating wheel can be rotated during operation to adjust the angle between the clip of the clip device and the tissue to be clamped
5. If the clamping position is correct, it is necessary to close the clip of the clip device at the desired position to be clamped, and the sliding handle needs to be moved to the proximal end until a slight movement resistance is overcome on the handle. If the clamping position is not correct, the clips of the clip device can be pushed out again to open and reposition
6. After the clip mechanism is closed, continue to move the slide handle proximally until a high degree of resistance is felt or heard. Continue to move the slide handle proximally until the gripper and delivery sections separate
7. After separation, slowly pull out the delivery part of the clip device out of the endoscope channel. Dispose of the delivery part of the clip device according to the national or local medical waste disposal regulations for inspection.
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ABOUT SOUDON:
The company covers an area of nearly 4,500 square meters, with standardized workshops, 100,000-level purification workshops and 10,000-level laboratories, equipped with advanced production and testing equipment.
About the Supplier
This supplier has been audited by TÜV Rheinland. Verify the report on the official TÜV Rheinland website with ID "MIC-ASR253569". Items marked "" are certified.
Company Profile
Zhejiang Soudon Medical Technology Co., Ltd. is an emerging brand company specializing in the research and development, production and sales of high-value medical devices for minimally invasive and interventional endoscopic surgery. The company was established in 2020 and is located in the world-famous beautiful West Lake - Hangzhou City. The company covers an area of nearly 3, 000 square meters, has standardized workshops, 100, 000-level purification workshops and laboratories, and is equipped with advanced production and testing equipment.
The company's core executives have more than 10 years of experience in medical device production and quality management. There are Lean Six Sigma experts and experts in the field of aseptic sterilization. They are all proficient in regulations and standards in the field of medical devices, providing a guarantee for reliable product quality production. The company has a number of senior and professional technical research and development talents, a number of independent intellectual property rights and patents, and has established strategic partnerships with many colleges and universities in Hangzhou, Shanghai and other cities.
The company takes continuous pursuit of innovation and excellence as its own responsibility, and our vision is to be a world-class professional supplier of medical devices! Taking caring for health and caring for life as the corporate mission! Integrity, innovation, excellence and win-win are the company's core business philosophy. Soudon Medical sincerely invites domestic and foreign partners to visit and guide!
Welcome to consult and negotiate! We look forward to being your long-term trusted partner!
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- Room 302, Floor 3, Building 4, No. 1, Nangonghe Road, Donghu Street, Yuhang District, Hangzhou, Zhejiang, China
-
Plant Area
- 3000 square meters
-
Number of Employees
- 70
-
Registered Capital
- 40,000,000 RMB
-
Terms of Payment
- LC, T/T, Western Union, D/P, PayPal, Small-amount payment
-
International Commercial Terms(Incoterms)
- EXW, CIF, FOB, CFR
-
Average Lead Time
-
Peak Season Lead Time: within 15 workdays, one month
Off Season Lead Time: within 15 workdays, one month -
Nearest Port
- Shanghai Port, Ningbo Port
-
Minimum Order Quantity
- 500 Pcs
-
Supply Chain Partners
- 10
Our Production Capability & Technical Expertise
-
Main Products
- Endoscopic Accessories
-
Production Lines
- 6
-
Production Machines
- Assembly Line, Precision Workshop
-
QA/QC inspectors
- 2 people
-
Inspection Type for Finished Products
- 100% inspection(Visual inspection & Function inspection)
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Customization from Samples, Customization from Designs, Minor Customization, Flexible customization, Full Customization
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 2 people
-
Traceability of Raw Materials
- Yes
-
Own Brand
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2020-12-10
-
Export Year
- 4 Years
-
Main Markets
- Mongolia
-
Repeat Buyers Choice
- 10%~30%
-
Number of Foreign Trading Staff
- 6
-
Overseas Agent/Branch
- No
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Cooperated with Fortune 500
- No
FAQ
- What is the warranty period?
- We provide a two-year quality guarantee. If there is damage due to non-human reasons, we offer free replacement.
- Can the product be customized?
- Yes, we support OEM services including logo printing, color customization, and detailed specification adjustments.
- What is the minimum order quantity?
- The minimum order quantity is 500 pieces.
- What are the lead times for production?
- Both peak and off-peak season lead times are within 15 working days to one month.
- How is the product sterilized?
- The product undergoes Ethylene Oxide Sterilization.
- What payment terms are accepted?
- We accept LC, T/T, Western Union, D/P, PayPal, and small-amount payments.
- Is the clip reusable?
- No, this is a disposable hemostatic clip designed for single use in medical institutions.
- What is the claw distance of the clip?
- The clip features a 16mm wide claw distance, beneficial for grasping large pieces of tissue.
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Product Groups
- Endoscopy
- Disposable Biopsy Forceps
- Disposable Hot Biopsy Forceps
- Disposable Sphincterotome
- Disposable Hemostatic Clips
- Disposable Biliary Drainage Catheter
- Disposable Endoscope Injection Needles
- Disposable Polypectomy Snares
- Disposable Guide Wire
- Disposable Stone Extraction Basket
- Disposable Endoscopic Ultrasound Suction Biopsy Needle
- Disposable Grasping Forceps
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