Active Member
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[China]
Address: #460,Fucheng Rd,Qiantang Area,Hangzhou,China
Contact name:Shen
Hangzhou Sunstone Technology Co., Ltd. |
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Pacesetter(TM) Multiple Clip Reusable Applier for Polymer Ligating Clips MCA-10CM
Features:
1. The main body of the multiple clip reusable applier is made of stainless steel and PEEK material, which can tolerate high-pressure steam sterilization.It is equipped with a flushing valve, which can be cleaned and sterilized without disassembly and assembly after surgery;
2. Cytotoxicity, sensitization, intracutaneous reactivity, pyrogen, acute systemic toxicity, genotoxicity, subchronic systemic toxicity and implantation experiments were performed. It proved that biocompatibility of the product meets the requirements of expected use and regulations;
3. multiple clipping, strong convenience; disposable, weak economic.
Product Spectification:
| Instructions | Check whether the device is cleaned, sterilized and packaged in good condition before use. Clip application should be performed by experienced medical staff. After using the clip applier, pull the reset button to return it to its original position and press the lock catch to remove the empty cartridge. See the IFU for details. |
| Product advantages | Multiple ligating clips can be placed continuously to save surgical
time; After the ligating clips are used up, reloading is allowed; The product is reusable, which is more convenient and economical. |
| Product structure and composition | Composed of a proboscis, a joint and a handle. |
| Precautions | 1. The product must be cleaned and sterilized in a timely manner
after use, and the device is not required to be disassembled during
the cleaning and sterilization process; 2. Avoid using corrosive solution to clean and sterilize the product; Avoid heavy pressure or impact on various components of the device; 3. Please confirm the model and brand of ligating clip and select the appropriate multiple clip applier for use. |
| Maintenance | Inspect the delivery/clamping trigger for smooth movement and no obvious deformation/defect of jaw before daily use; it is recommended to send it to the manufacturer for maintenance once a year. |
Company Profile:
Hangzhou Sunstone Technology Co., Ltd, was established in 2005, is a manufacturing enterprise dedicated to the R&D and sales of innovative medical devices. The enterprise park covers an area of more than 7,000 square meters, and the enterprise assets exceed 30 million US dollars. The company is located in Hangzhou, China, with a production and office area of 20,000 square meters, of which the ISO 8 class cleanroom exceeds 1,000 square meters and the ISO 7 class cleanroom exceeds 500 square meters. Sunstone Technology is the first national high-tech enterprise dedicated to the research and development of absorbable medical consumables in Zhejiang Province, China. It has obtained the qualification of high-tech enterprise research and development center of Zhejiang Province Science and Technology Department of Innovation Medical Devices. Several of the unique medical devices we have developed have applied for Chinese and international patents. These projects are in different stages of research and development, some of which have entered the stage of registration and approval in China, and some in the stage of EU CE certification.
