Meniscus suture system - NMPA Registration 国械注准20243131811
Access comprehensive regulatory information for Meniscus suture system in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243131811 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on September 19, 2024.
This page provides complete registration details including registrant information, province location (Tianjin), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
This product is used as a suture closure in endoscopic soft tissue repair surgery for meniscal repair surgery.
该产品在内窥镜下软组织修复手术中作为缝合闭合器使用，用于半月板修复手术。
The meniscus suture system consists of two parts: a meniscus suture gun and a thread pusher. The implants included in the meniscus suture gun include 2 fixing rods and sutures. The fixed rod is made of OPTIMA-LT3 polyetheretherketone material in accordance with the YY/T 0660 standard; The sutures are made of white ultra-high molecular weight polyethylene and blue polypropylene with an uncoated finish, and the blue polypropylene contains copper phthalocyanine (CAS: 147-14-8) blue dye in accordance with USP United States Pharmacopoeia. The meniscus suture gun (inserter rod: 304 stainless steel, inner guidewire: 630 stainless steel) and knot pusher trimmer (outer tube: 304 stainless steel, wire crossing rod: 630 stainless steel) metal parts are all in accordance with ASTM F899 standards. The limiting sleeve is made of polyamide in accordance with the GB 4806.6 standard. The heat shrink tubing is made of polyurethane in accordance with the YY/T 1557 standard. The product is delivered in sterilized packaging, sterilized with ethylene oxide, and the sterilization is valid for 5 years.
半月板缝合系统由半月板缝合枪和推结剪线器两部分组成。半月板缝合枪中包含的植入物包括2个固定棒和缝线。固定棒由符合YY/T 0660标准规定的OPTIMA-LT3聚醚醚酮材料制成；缝线由白色超高分子量聚乙烯和蓝色聚丙烯材料制成，表面无涂层处理，蓝色聚丙烯中含有符合USP美国药典的酞菁铜（CAS：147-14-8）蓝色染料。半月板缝合枪（插入器杆：304不锈钢，内导丝：630不锈钢）、推结剪线器（外管：304不锈钢，过线杆：630不锈钢）金属部分均符合ASTM F899标准规定。限位套管由符合GB 4806.6标准规定的聚酰胺制成。热缩管由符合YY/T 1557标准规定的聚氨酯制成。产品以灭菌包装形式交付，采用环氧乙烷灭菌，灭菌有效期5年。