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Sterling SL Monorail PTA Balloon Dilatation Catheter(PTA球囊扩张导管)
| Brand | Boston（波士顿） |
|---|---|
| Manufacturer | Boston Scientific Corporation波士顿科学公司 |
| Production Address | Two Scimed Place, Maple Grove, MN 55311-1566, USA |
| Intended Use | This product is suitable for percutaneous transluminal angioplasty (PTA) of the peripheral vascular system (including the iliac artery, femoral artery, iliofemoral artery, popliteal artery, infrapopliteal artery, and renal artery), and is also suitable for treating occlusive lesions in natural or artificial arteriovenous fistulas for hemodialysis.该产品适用于外周血管系统（包括髂动脉、股动脉、髂股动脉、腘动脉、膝下动脉以及肾动脉）的经皮腔内血管成形术（PTA），并适用于治疗天然或人造透析用动静脉瘘的堵塞病变。 |
| References | H74939148251510 ……… |
| Manufacturer’s Website | https://www.bostonscientific.com/en-US/products/catheters–balloon/Sterling-and-Sterling-SL-Balloon-Dilatation-Catheter.html |
| Product Brochure | |
| Registration Certificate | 国械注进20163033013 |
Brand
The product is designed with a coaxial structure, consisting of a handle (polycarbonate), a sheath (polyamide), an outer shaft (nylon 12), a three-layer inner shaft (Pebax 7233, polyethylene copolymer, high-density polyethylene), a balloon (Pebax 7233), a marker band (18K gold), a proximal marker (hot stamping foil), a tapered tip (nylon elastomer), and a balloon protection device (polytetrafluoroethylene). The distal end of the catheter is coated with a hydrophilic coating (Bioslide) and a hydrophobic coating (Xtra). The product is sterilized with ethylene oxide, for single-use only, and has a shelf life of two years.
该产品采用同轴设计，由手柄（聚碳酸酯）、缓冲器（聚氨酸）、外轴（尼龙12）、三层式内轴（Pebax 7233、聚乙烯共聚物、高密度聚乙烯）、球囊（Pebax 7233）、标记带（18K金）、近端标记（烫印箔）、缓冲尖端（尼龙弹性体）、球囊保护装置（聚四氟乙烯）组成。导管远端涂覆有亲水性涂层（Bioslide）和疏水涂层（Xtra）。环氧乙烷灭菌，产品一次性使用，有效期两年。
Product List
| REF | GTIN | Classification Code | Description |
|---|---|---|---|
| H74939148201010 | 08714729782216 | 03-13-06 | Sterling SL OTW 2 x 100 x 150 |
| H74939148201090 | 08714729782391 | 03-13-06 | Sterling SL OTW 2 x 100 x 90 |
| H74939148201210 | 08714729782223 | 03-13-06 | Sterling SL OTW 2 x 120 x 150 |
| H74939148201290 | 08714729782407 | 03-13-06 | Sterling SL OTW 2 x 120 x 90 |
| H74939148201510 | 08714729782230 | 03-13-06 | Sterling SL OTW 2 x 150 x 150 |
| H74939148201590 | 08714729782414 | 03-13-06 | Sterling SL OTW 2 x 150 x 90 |
| H74939148208010 | 08714729782247 | 03-13-06 | Sterling SL OTW 2 x 80 x 150 |
| H74939148208090 | 08714729782421 | 03-13-06 | Sterling SL OTW 2 x 80 x 90 |
| H74939148251010 | 08714729782254 | 03-13-06 | Sterling SL OTW 2.5 x 100 x 150 |
| H74939148251090 | 08714729782438 | 03-13-06 | Sterling SL OTW 2.5 x 100 x 90 |
| H74939148251210 | 08714729782261 | 03-13-06 | Sterling SL OTW 2.5 x 120 x 150 |
| H74939148251290 | 08714729782445 | 03-13-06 | Sterling SL OTW 2.5 x 120 x 90 |
| H74939148251510 | 08714729782278 | 03-13-06 | Sterling SL OTW 2.5 x 150 x 150 |
| H74939148251590 | 08714729782452 | 03-13-06 | Sterling SL OTW 2.5 x 150 x 90 |
| H74939148258010 | 08714729782285 | 03-13-06 | Sterling SL OTW 2.5 x 80 x 150 |
| H74939148258090 | 08714729782469 | 03-13-06 | Sterling SL OTW 2.5 x 80 x 90 |
| H74939148301010 | 08714729782292 | 03-13-06 | Sterling SL OTW 3 x 100 x 150 |
| H74939148301090 | 08714729782476 | 03-13-06 | Sterling SL OTW 3 x 100 x 90 |
| H74939148301210 | 08714729782308 | 03-13-06 | Sterling SL OTW 3 x 120 x 150 |
| H74939148301290 | 08714729782483 | 03-13-06 | Sterling SL OTW 3 x 120 x 90 |
| H74939148301510 | 08714729782315 | 03-13-06 | Sterling SL OTW 3 x 150 x 150 |
| H74939148301590 | 08714729782490 | 03-13-06 | Sterling SL OTW 3 x 150 x 90 |
| H74939148308010 | 08714729782322 | 03-13-06 | Sterling SL OTW 3 x 80 x 150 |
| H74939148308090 | 08714729782506 | 03-13-06 | Sterling SL OTW 3 x 80 x 90 |
| H74939148351010 | 08714729782339 | 03-13-06 | Sterling SL OTW 3.5 x 100 x 150 |
| H74939148351090 | 08714729782513 | 03-13-06 | Sterling SL OTW 3.5 x 100 x 90 |
| H74939148351210 | 08714729782346 | 03-13-06 | Sterling SL OTW 3.5 x 120 x 150 |
| H74939148351290 | 08714729782520 | 03-13-06 | Sterling SL OTW 3.5 x 120 x 90 |
| H74939148351510 | 08714729782353 | 03-13-06 | Sterling SL OTW 3.5 x 150 x 150 |
| H74939148351590 | 08714729782537 | 03-13-06 | Sterling SL OTW 3.5 x 150 x 90 |
| H74939148358010 | 08714729782360 | 03-13-06 | Sterling SL OTW 3.5 x 80 x 150 |
| H74939148358090 | 08714729782544 | 03-13-06 | Sterling SL OTW 3.5 x 80 x 90 |
| H74939148401010 | 08714729782551 | 03-13-06 | Sterling SL OTW 4 x 100 x 150 |
| H74939148401210 | 08714729782377 | 03-13-06 | Sterling SL OTW 4 x 120 x 150 |
| H74939148401290 | 08714729782568 | 03-13-06 | Sterling SL OTW 4 x 120 x 90 |
| H74939148401510 | 08714729782384 | 03-13-06 | Sterling SL OTW 4 x 150 x 150 |
| H74939148401590 | 08714729782575 | 03-13-06 | Sterling SL OTW 4 x 150 x 90 |
| H74939148408010 | 08714729782582 | 03-13-06 | Sterling SL OTW 4 x 80 x 150 |
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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