Experimental Design, Implementation and Quality Assurance (Exposure Draft) 2019/11/27 II, III Technical Guidelines for Clinical Evaluation of Medical Devices Using General Real-World Data (Exposure Draft) 2019/12/13 II, III Technical Guidelines for Clinical Evaluation of General Medical Devices (Exposure Draft) 2020/1/2 II, III Guidelines for Review of Evaluation Methods and Characterization Techniques for Unknown Leachables in General Medical Devices (Exposure Draft) 2020/6/24 II,Titanium 6Al4V wire, III 8. Main detection mechanism of biliary stent The qualified testing institutes for biliary stent testing mainly include: -Tianjin Medical Equipment Test Center-GB/T 25304 Full Project -Shandong Medical Equipment Product Quality Inspection Center-GB/T 25304 Project -Beijing Medical Equipment Quality Supervision and Inspection Center-GB/T 25304 Project Attachment: Summary of Biliary Stent Registration Certificate Summary of domestic biliary stent registration certificates: Serial Number Manufacturer and Registration Number Product Description Nanjing Minimally Invasive Medical Technology Co., Ltd. (1) The 20153130197 covered biliary stent is a cylindrical stent made of titanium-nickel shape memory alloy meeting the requirements of GB24627, and the surface of the stent is covered with silicone rubber film. Support end shape: straight cylindrical mouth. Stent diameter 6mm, 8mm, 10mm, length 40mm, 50mm, 60mm, 70mm, 80mm. 9Taewoong Medical Co.,Ltd. (1) National Instrument Injection 20163462793 Biliary Tract Uncovered Stent Niti-S Biliary Uncovered Stent This product consists of a handle, a Y-shaped connector, a pusher, an outer sheath, an intermediate catheter, a radiation-detectable marker, a yellow marker, a bindings, an inner catheter, a tip and a stent. The stent was made of nickel-titanium alloy, and the radiolabeling materials were 316 L stainless steel and platinum-iridium alloy. The delivery system is divided into endoscopic delivery system and percutaneous delivery system, which is made of ABS, 304 stainless steel, PTFE, PEBAX, platinum-iridium alloy, nylon, polyolefin, polyetheretherketone, tungsten and other materials. The stent is divided into S-type stent and D-type stent according to different weaving methods. Ethylene oxide sterilization, disposable product. Valid for 3 years. The product is mainly used for biliary stricture caused by primary and/or secondary malignant/benign tumors to help restore the smooth of the stricture. (2) Niti-S Biliary Covered Stent, a 20163462808 biliary covered stent, is composed of a stent and a delivery system. The braiding type of the stent is S-type, the main body material is nickel-titanium alloy, the ray detectability marker material is 316L stainless steel and platinum-iridium alloy, the coating material is silicone, and the stent is provided with nylon material strings. The delivery system is divided into an endoscope delivery system and a percutaneous delivery system and consists of a handle, a Y-shaped connector, a pusher, an outer sheath, an intermediate catheter, a ray detectable marker, a yellow marker,ti6al4v, an bindings, an inner catheter and a tip. Ethylene oxide sterilization, disposable product. The product is mainly used for biliary stricture caused by primary and/or secondary malignant/benign tumors to help restore the smooth of the stricture. END Return to Sohu to see more Responsible Editor:. yunchtitanium.com
Biliary stent product registration case analysis _ Materials
