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Medical Disposable Consumables for Contrast Guide Silk Operations
Description
Basic Info.
| Model NO. | Inno-Hydrowire |
| FDA Certificate Number | K172187 |
| Minimum Unit of Measurement | 1 Set/Bag |
| Warranty | 1 Year |
| Approval Scope | Class III |
| OEM | Accept OEM |
| After-Sale Service | Free Spare Parts |
| Stiffiness | Standard or Hard |
| Certification | ISO13485;FDA;Nmpa |
| Tip Shape | Angle or Straight |
| Qty | 5 |
| Flex L | 3cm |
| Transport Package | Cardboard Box |
| Specification | Full Specifications |
| Trademark | Innomed |
| Origin | Suzhou China |
| HS Code | 9018909919 |
| Production Capacity | 50000/Y |
Product Description
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 Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vascular system during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. It consists of a Nickel-Titanium alloy core wire; a polymer coating (Pebax containing BaSO4 for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The Inno-Hydrowire includes a 3cm flexible tip. The Inno-Hydrowire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire utilized for rotating and controlling the guidewire. The guidewires are packaged within a cardboard box which contains five individual guidewires.Product advantage 1. Made of nickel-titanium core wire, with good torsional control and support. 2. Surface coated with hydrophilic coating, good stability of the coating, increasing the lubricity of the guide wire. 3. Good development effect and precise positioning under X-ray equipment. 4. 0.018 inch and below guidewire can reach the fine vessels. Product Performance
| Diameter(inch) | Wire core hardness | Tip morphology | Length(cm) |
| 0.014 | Standard type | Straight&Angle type | 80/150/180/260 |
| 0.018 | Standard type | Straight&Angle type | 80/150/180/260 |
| 0.022 | Standard type | Straight&Angle type | 80/150/180/260 |
| 0.025 | Standard type | Straight&Angle type | 80/150/180/260 |
| 0.032 | Standard type | Straight&Angle type | 80/150/180/260 |
| 0.035 | Standard&hard type | Straight&Angle type | 80/150/180/260 |
| 0.038 | Standard type | Straight&Angle type | 80/150/180/260 |
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.
Application range
It is mainly used for preoperative contrast diagnosis, guided contrast catheter, interventional therapy, guided balloon dilation catheter or stent.
Indications for use
The Inno-Hydrowire Guidewire is intended to direct a catheter to the desired anatomical location in the vascular system during diagnostic or interventional procedures. This device is not intended for neurovasculature or coronary vasculature.
Contraindications
The Inno-Hydrowire Guidewire is not intended for use in:• The neurovasculature• The coronary vasculature• Patient judged not acceptable for percutaneous intervention
Warnings
•Do not manipulate or withdraw the guidewire through a metal needle or dilator.•Do not advance or withdraw the device against resistance of unknown origin. Determine the cause by X-Ray and take necessary actions. Excessive force against resistance may result in vessel perforation /or damage.• Do not attempt to use the guidewire if it has been bent, kinked or damaged.• Do not put the guidewire into organic solvent, which may cause damage to the guidewire or its lubricity.• Do not shape (reshape) the guidewire by any means. Reshaping the wire may cause damage and fracture.• A torquer is included with guidewire, which is used to rotate and control the device. It cannot be inserted into the patient at any time. • The guidewire is to be used by a physician who is thoroughly trained in the insertion, manipulation and observation of guidewires under fluoroscopy.• The device should be disposed safely and properly, following local regulations and laws.
Precautions
•Physicians should evaluate the suitability of the device or select appropriate specifications of the device according to the patient's own condition and his/her own training skills and experience.• The device must be moistened prior to removal from the dispenser in order to ensure lubricity. Heparinized physiological saline solution is recommended.• Prior to reinsertion of the device during the same procedure, the wire should be rinsed in heparinized saline solution. Residual blood or other foreign matter can be removed by wiping the device with gauze that has been moistened with heparinized saline solution. Cleaning will not completely remove foreign substances, therefore the device is for SINGLE USE only.
Directions for use
1) Prepare the guidewire and any interfacing devices according to the manufacturer's directions.2) Using sterile aseptic technique, remove the guidewire and the loop together from the package in the sterile field.3) Using a syringe, flush the loop with heparinized saline solution through the tube of the loop to increase surface lubricity.4) Remove the guidewire from the loop and inspect the guidewire prior to use; verify that it is lubricated.NOTE: If the guidewire cannot be easily removed from the loop, inject more heparinized saline solution into the loop.5) Prior to use, inject the catheter with heparinized physiological saline solution to ensure the guidewire can move easily within the catheter.6) Tighten the torque at the proximal end of the wire and make sure there is no movement between them.7) Keep at least 5cm of the tip of the wire out of the loop during introduction. Gently push and reverse the guidewire under fluoroscopy.8) Holding the guidewire in position, advance the catheter over the guidewire and into the target lesion.9) Complete the procedure and remove the guidewire and catheter according to standard procedural protocol.10) Dispose of the guidewire according to your facilities hazardous waste policy.
Product Line
Certificate
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