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Name

V-18 Control Wire Guidewire with ICE Hydrophilic Coating带有亲水涂层的可控导丝

Brand Boston(波士顿)
Manufacturer Boston Scientific Corporation波士顿科学公司
Production Address 302 Parkway, Global Park, Heredia, Costa Rica
Intended Use The guidewire can be twisted for selective placement of diagnostic or treatment catheters. This device is for peripheral use only. Each guidewire is accompanied by a torquer to facilitate directional manipulation of the guidewire. The 110cm V-18 Control Wire guidewire is suitable for routine vascular use, including placement of PTA balloon catheters requiring a 0.018 in guidewire in AV access surgery for hemodialysis. The 150cm, 200cm, and 300cm V-18 Control Wire guidewires are suitable for routine vascular use.导丝可以扭转,以便于选择性地放置诊断导管或治疗导管。本器械仅供外围使用。随每根导丝附带了一只扭转装置,以方便对导丝进行方向性操作。110cm V-18 Control Wire导丝适用于常规血管内使用,包括在血液透析AV通路手术中需要0.018 in导丝的PTA球囊导管的放置。150、200和300cm V-18 Control Wire导丝适用于常规血管内使用。
References M001468540 ………
Manufacturer’s Website
Product Brochure
Registration Certificate 国械注进20163032156

Brand

This product consists of a core wire and a distal polymer sheath. The polymer sheath is coated with an ICE hydrophilic coating, while the proximal portion of the guidewire is coated with PTFE. The manufacturing materials are as follows: core wire – 304V stainless steel, polymer sheath – polyurethane containing tungsten. The product is sterilized with ethylene oxide and is for single use only. The product has a shelf life of 25 months.

该产品由芯线、远端聚合物套组成。聚合物套管涂覆ICE亲水涂层,导丝近端部分涂覆PTFE涂层。制造材料为芯线:304V不锈钢,聚合物套管:含有钨的聚氨酯。产品经环氧乙烷灭菌,一次性使用。产品有效期25个月。

Product List

REFGTINClassification CodeDescription
M0014685400871472907020703-13-16V-18 —— .018/8/300
M0014685000871472907018403-13-16V-18 —— .018/8/150
M0014685800871472907022103-13-16V-18 —— .018/12/200
M0014685200871472907019103-13-16V-18 —— .018/8/200
M0014684800871472971556603-13-16V-18 —— .018/8/110
M0014686000871472907023803-13-16V-18 —— .018/12/300
M0014685600871472907021403-13-16V-18 —— .018/12/150
Risk-Based Classification风险管理类别

Product Status产品状态

Active

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