Amplatz Goose Neck Snare Kit“鹅颈”式抓捕器套件

Brand	EV3（医伟司安）
Manufacturer	ev3, Inc.医伟司安股份有限公司
Production Address	4600 Nathan Lane North, Plymouth, MN, 55442, United States
Intended Use	This product is used to grasp or control foreign bodies in the cardiovascular system or hollow viscera. The operation process includes the repositioning of venous indwelling catheters, the removal of fibrous sheaths from venous indwelling catheters, and the assistance in central venous puncture surgery.该产品用于在心血管系统或中空的内脏中抓取或控制异物。操作过程包括静脉留置导管的再定位、静脉留置导管纤维鞘脱模和辅助中央静脉穿刺手术。
References	GN1500, GN2000 ……
Manufacturer’s Website	https://europe.medtronic.com/xd-en/healthcare-professionals/products/cardiovascular/snares/amplatz.html
Product Brochure
Registration Certificate	国械注进20173030400

Brand

The product includes a retriever (with a guiding sleeve and a rotator) and a catheter. The retriever consists of a retriever pole and a retriever ring. The core of the retriever pole is made of nickel-titanium alloy, and the outer layer is made of polytetrafluoroethylene. The retriever ring is made of tungsten wire. It is sterilized with ethylene oxide and has a shelf life of 5 years. It is for one-time use.

该产品包括一个抓捕器（带导引套管和扭转器）和一根导管。抓捕器由抓捕器杆、抓捕环组成；抓捕器杆芯由镍钛合金制成，外层为聚四氟乙烯；抓捕环由钨丝金环制成。环氧乙烷灭菌，有效期5年，一次性使用。

Risk-Based Classification风险管理类别	Class III （第三类）
Product Status产品状态	Active

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