Complaint
Company Profile
Suzhou Innomed Medical Device Co., Ltd was founded in January 2013, and is a high-tech enterprise specializing in the research and development and manufacturing of innovative cardiovascular and cerebrovascular implantable medical devices and interventional high-end consumables.
The company was founded by Dr. XIAOYAN SHAWN GONG, a talented person introduced by the National Major Entrepreneurial Talent Program, and has a strong technical team recognized in the industry, with profound R&D experience in the field of medical device manufacturing for cardiovascular, neurological and structural heart diseases. The company has many product development projects, including cardiology, cardiac surgery, vascular surgery and other multidisciplinary fields, and has built three major technology platforms: vascular intervention, vascular implantation and structural heart disease. The peripheral vascular stents and venous stents under development have been granted the "green channel" for special approval of national innovative medical devices. At present, the company has 6 overseas doctors, 12 masters and nearly 100 employees, and has built a professional production center with 10,000-grade clean plant, R&D and office, covering an area of over 10,000 square meters, and has passed ISO13485 quality management system certification. The company has obtained three NMPA national class III medical device registrations including guidewires and contrast guidewires, and two class II medical device registrations. Several products have obtained 510k certification in USA and CE certification in EU, and entered many countries including Poland, Athens and Latvia. Meanwhile, the company has reached a good long-term cooperation with many famous universities, enterprises and hospitals at home and abroad. The company is currently applying for nearly 100 patents, many of which have entered Europe and the United States.
In 2017, the company was awarded as a national high-tech enterprise, and in 2019, it was awarded as one of the top 10 medical device solution providers in Asia Pacific by Outlook Medtech. With market and R&D as the driving force to move forward, Innomed Medical has built a technological innovation platform and continuously launched innovative medical devices with independent intellectual property rights.
Product Description
The zebra guidewire is widely used in endoscopic surgery. Because of its central mental core, it is not easy to break or shear off within the urinary tract. We report a case about the breakage of zebra guidewire in ureteroscopy (URS) with Holmium: YAG laser lithotripsy. It is easily to be managed by percutaneous access or open surgery. For the purpose of minimal invasiveness and risk, we performed a retrograde flexible ureteroscopy and extracted it successfully without any complication. To our knowledge, this is the first case report on flexible ureteroscopy to remove the residual tip of damaged guidewire in renal.
Product advantage
1. Easy relocation feature.
2. Ensuring normal venous blood circulation.
3. Easy visual use.
4. Designed for reliable access and reduced trauma.
5. The striped pattern is designed to provide clear endoscopic visualization of wire movement.
6. The platinum distal tip can be seen under fluoroscopy to help confirm guidewire position.
7. Designed to reduce time spent manipulating and replacing multiple cables.
8. Flat wire stainless steel construction provides a rigid guide wire for improved instrumentation and instrument placement.
Technical specs
They are guide wires used to create a safe working channel in endoscopic entrances. It has strong pushing ability thanks to its resistant nitinol core. It can easily pass through the working channel thanks to its super smooth PTFE-coated outer surface. Yellow and black colors increase the traceability of the guide wire under X-ray rays. Due to its hydrophilic structure, it does not drip and provides lubricity when in contact with water. It provides more options and control to the doctor with its straight and angled tip options.
Usage method
Before making a hand, first check that the packaging is intact and confirm that the product is within the expiration date of the fire bacteria.
When used, the package is torn from the opening, the guide wire is removed, and the guide wire is used in conjunction with instruments such as cystoscopy or ureteroscopy to deliver the guide wire to the affected area, and then other instruments can be directed, such as the catheter along the guide wire to reach the affected area smoothly, and then the guide wire is extracted with the help of the push tube.
Precautions
1. Before using this product, check whether the packaging is intact, the packaging is damaged, and do not use it.
2. This product is limited to single-use, and should be used immediately after opening the package; Destroy after use
3. This product is sterilized by ethylene oxide (STERILIEO), and the sterilization validity period is three years.
4. Those who have no relevant equipment and no operation experience should use it with caution.
5. In order to ensure patient safety, if you find possible quality doubts during use, please stop using it immediately and quickly contact the manufacturer.
6. During transportation, it should prevent rain, prevent sunfall, prevent heavy pressure, and store in a cool, dry, well-ventilated, non-corrosive gas room with relative humidity of no more than 80%.
Storage and transportation conditions
The product is stored in an environment of normal temperature, clean, good ventilation and no corrosive gas, avoiding direct sunlight and avoiding storage in abnormal temperature and high humidity environment.
Certificate
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