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Sterling 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 intravascular angioplasty of the peripheral vascular system, including the iliac artery, femoral artery, popliteal artery, infrapopliteal artery, renal artery, and carotid artery. It is also suitable for the treatment of occlusive lesions in natural or synthetic arteriovenous fistulas for dialysis. The device is also suitable for post-dilation of balloon-expandable stents or self-expanding stents in the peripheral vascular system.该产品适用于外周血管系统（包括髂动脉、股动脉、腘动脉、膝下动脉、肾动脉以及颈动脉）的经皮腔内血管成形术，并适用于治疗天然或人造透析用动静脉瘘的堵塞病变。本器械还适用于外周血管系统中的球囊扩张支架或自扩张支架的后扩张。 |
| References | H74939031403010 ……… |
| 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20163030734 |
Brand
This product is a rapid exchange balloon dilatation catheter with a semi-compliant balloon fixed at its distal end. The balloon catheter is designed with a coaxial shaft. The outer lumen is used for balloon dilation, while the guidewire lumen (made of HDPE and dye) allows the catheter to be advanced using a 0.014in/0.018in (0.36mm/0.46mm) guidewire, enabling it to reach and pass through the narrow site that requires dilation. The catheter has a tapered tip to facilitate its advancement and passage through the narrow site. With two radiopaque markers (one located at the proximal end and one at the distal end) that are not visible on X-ray, the balloon can be precisely positioned under X-ray fluoroscopy. The product is sterilized with ethylene oxide and is for single use.
该产品是快速交换球囊扩张导管，在其末端固定有一个半顺应性球囊。球囊导管采用同轴管身设计。外腔用于球囊扩张，导丝腔（内层材料为HDPE及染料）可以通过0.014in／0.018in（0.36 mm／0.46 mm）的导丝，便于导管向前移动，使其到达并通过需要扩张的狭窄部位。导管有一个渐细的末端，便于导管向前移动，使其到达并通过狭窄部位。通过两个不透X射线的标记（一个位于近端、一个位于远端）在X射线透视下，能够精确定位球囊。产品经环氧乙烷灭菌，一次性使用。
Product List
| REF | GTIN | Classification Code | Description |
|---|---|---|---|
| H74939031302010 | 08714729755586 | 03-13-06 | F/G,STERLING,MR,3.0x20/135(4F) |
| H74939031302210 | 08714729859208 | 03-13-06 | FGSTERLINGMR,3.0mmx220mmx150cm(4F) |
| H74939031302290 | 08714729859215 | 03-13-06 | FGSTERLINGMR,3.0mmx220mmx90cm(4F) |
| H74939031303010 | 08714729756873 | 03-13-06 | F/G,STERLING,MR,3.0x30/135(4F) |
| H74939031304010 | 08714729756880 | 03-13-06 | F/G,STERLING,MR,3.0x40/135(4F) |
| H74939031306010 | 08714729756897 | 03-13-06 | F/G,STERLING,MR,3.0x60/135(4F) |
| H74939031352010 | 08714729756903 | 03-13-06 | F/G,STERLING,MR,3.5x20/135(4F) |
| H74939031352210 | 08714729859222 | 03-13-06 | FGSTERLINGMR,3.5mmx220mmx150cm(4F) |
| H74939031352290 | 08714729859239 | 03-13-06 | FGSTERLINGMR,3.5mmx220mmx90cm(4F) |
| H74939031353010 | 08714729756910 | 03-13-06 | F/G,STERLING,MR,3.5x30/135(4F) |
| H74939031354010 | 08714729756927 | 03-13-06 | F/G,STERLING,MR,3.5x40/135(4F) |
| H74939031356010 | 08714729859246 | 03-13-06 | FGSTERLINGMR,3.5mmx60mmx150cm(4F) |
| H74939031356090 | 08714729859253 | 03-13-06 | FGSTERLINGMR,3.5mmx60mmx90cm(4F) |
| H74939031401080 | 08714729756934 | 03-13-06 | F/G,STERLING,MR,4.0x10/80(4F) |
| H74939031401510 | 08714729859260 | 03-13-06 | FGSTERLINGMR,4.0mmx15mmx135cm(4F) |
| H74939031401580 | 08714729756941 | 03-13-06 | F/G,STERLING,MR,4.0x15/80(4F) |
| H74939031402010 | 08714729756958 | 03-13-06 | F/G,STERLING,MR,4.0x20/135(4F) |
| H74939031402080 | 08714729756965 | 03-13-06 | F/G,STERLING,MR,4.0x20/80(4F) |
| H74939031402110 | 08714729859277 | 03-13-06 | FGSTERLINGMR,4.0mmx200mmx150cm(4F) |
| H74939031402190 | 08714729859284 | 03-13-06 | FGSTERLINGMR,4.0mmx200mmx90cm(4F) |
| H74939031402210 | 08714729859291 | 03-13-06 | FGSTERLINGMR,4.0mmx220mmx150cm(4F) |
| H74939031402290 | 08714729859307 | 03-13-06 | FGSTERLINGMR,4.0mmx220mmx90cm(4F) |
| H74939031403010 | 08714729756972 | 03-13-06 | F/G,STERLING,MR,4.0x30/135(4F) |
| H74939031403080 | 08714729756989 | 03-13-06 | F/G,STERLING,MR,4.0x30/80(4F) |
| H74939031404010 | 08714729756996 | 03-13-06 | F/G,STERLING,MR,4.0x40/135(4F) |
| H74939031404080 | 08714729757009 | 03-13-06 | F/G,STERLING,MR,4.0x40/80(4F) |
| H74939031406010 | 08714729757016 | 03-13-06 | F/G,STERLING,MR,4.0x60/135(4F) |
| H74939031451110 | 08714729859314 | 03-13-06 | FGSTERLINGMR,4.5mmx100mmx150cm(4F) |
| H74939031451190 | 08714729859321 | 03-13-06 | FGSTERLINGMR,4.5mmx100mmx90cm(4F) |
| H74939031451510 | 08714729859338 | 03-13-06 | FGSTERLINGMR,4.5mmx15mmx135cm(4F) |
| H74939031451580 | 08714729757023 | 03-13-06 | F/G,STERLING,MR,4.5x15/80(4F) |
| H74939031451610 | 08714729859345 | 03-13-06 | FGSTERLINGMR,4.5mmx150mmx150cm(4F) |
| H74939031451690 | 08714729859352 | 03-13-06 | FGSTERLINGMR,4.5mmx150mmx90cm(4F) |
| H74939031452010 | 08714729757030 | 03-13-06 | F/G,STERLING,MR,4.5x20/135(4F) |
| H74939031452080 | 08714729757047 | 03-13-06 | F/G,STERLING,MR,4.5x20/80(4F) |
| H74939031452210 | 08714729859369 | 03-13-06 | FGSTERLINGMR,4.5mmx220mmx150cm(4F) |
| H74939031452290 | 08714729859376 | 03-13-06 | FGSTERLINGMR,4.5mmx220mmx90cm(4F) |
| H74939031453010 | 08714729757054 | 03-13-06 | F/G,STERLING,MR,4.5x30/135(4F) |
| H74939031453080 | 08714729757061 | 03-13-06 | F/G,STERLING,MR,4.5x30/80(4F) |
| H74939031454010 | 08714729757078 | 03-13-06 | F/G,STERLING,MR,4.5x40/135(4F) |
| H74939031454080 | 08714729757085 | 03-13-06 | F/G,STERLING,MR,4.5x40/80(4F) |
| H74939031456010 | 08714729859383 | 03-13-06 | FGSTERLINGMR,4.5mmx60mmx135cm(4F) |
| H74939031456080 | 08714729859390 | 03-13-06 | FGSTERLINGMR,4.5mmx60mmx80cm(4F) |
| H74939031501080 | 08714729757092 | 03-13-06 | F/G,STERLING,MR,5.0x10/80(4F) |
| H74939031501110 | 08714729859406 | 03-13-06 | FGSTERLINGMR,5.0mmx100mmx150cm(4F) |
| H74939031501190 | 08714729859413 | 03-13-06 | FGSTERLINGMR,5.0mmx100mmx90cm(4F) |
| H74939031501510 | 08714729859420 | 03-13-06 | FGSTERLINGMR,5.0mmx15mmx135cm(4F) |
| H74939031501580 | 08714729757108 | 03-13-06 | F/G,STERLING,MR,5.0x15/80(4F) |
| H74939031501610 | 08714729859437 | 03-13-06 | FGSTERLINGMR,5.0mmx150mmx150cm(4F) |
| H74939031501690 | 08714729859444 | 03-13-06 | FGSTERLINGMR,5.0mmx150mmx90cm(4F) |
| H74939031502010 | 08714729756194 | 03-13-06 | F/G,STERLING,MR,5.0x20/135(4F) |
| H74939031502080 | 08714729757115 | 03-13-06 | F/G,STERLING,MR,5.0x20/80(4F) |
| H74939031502110 | 08714729859451 | 03-13-06 | FGSTERLINGMR,5.0mmx200mmx150cm(4F) |
| H74939031502190 | 08714729859468 | 03-13-06 | FGSTERLINGMR,5.0mmx200mmx90cm(4F) |
| H74939031502210 | 08714729859475 | 03-13-06 | FGSTERLINGMR,5.0mmx220mmx150cm(4F) |
| H74939031502290 | 08714729859482 | 03-13-06 | FGSTERLINGMR,5.0mmx220mmx90cm(4F) |
| H74939031503010 | 08714729757122 | 03-13-06 | F/G,STERLING,MR,5.0x30/135(4F) |
| H74939031503080 | 08714729757139 | 03-13-06 | F/G,STERLING,MR,5.0x30/80(4F) |
| H74939031504010 | 08714729757146 | 03-13-06 | F/G,STERLING,MR,5.0x40/135(4F) |
| H74939031504080 | 08714729757153 | 03-13-06 | F/G,STERLING,MR,5.0x40/80(4F) |
| H74939031506010 | 08714729757160 | 03-13-06 | F/G,STERLING,MR,5.0x60/135(4F) |
| H74939031551110 | 08714729859499 | 03-13-06 | FGSTERLINGMR,5.5mmx100mmx150cm(4F) |
| H74939031551190 | 08714729859505 | 03-13-06 | FGSTERLINGMR,5.5mmx100mmx90cm(4F) |
| H74939031551510 | 08714729859512 | 03-13-06 | FGSTERLINGMR,5.5mmx15mmx135cm(4F) |
| H74939031551580 | 08714729757177 | 03-13-06 | F/G,STERLING,MR,5.5x15/80(4F) |
| H74939031551610 | 08714729859529 | 03-13-06 | FGSTERLINGMR,5.5mmx150mmx150cm(4F) |
| H74939031551690 | 08714729859536 | 03-13-06 | FGSTERLINGMR,5.5mmx150mmx90cm(4F) |
| H74939031552010 | 08714729755579 | 03-13-06 | F/G,STERLING,MR,5.5x20/135(4F) |
| H74939031552080 | 08714729757184 | 03-13-06 | F/G,STERLING,MR,5.5x20/80(4F) |
| H74939031552210 | 08714729859543 | 03-13-06 | FGSTERLINGMR,5.5mmx220mmx150cm(4F) |
| H74939031552290 | 08714729859550 | 03-13-06 | FGSTERLINGMR,5.5mmx220mmx90cm(4F) |
| H74939031553010 | 08714729757191 | 03-13-06 | F/G,STERLING,MR,5.5x30/135(4F) |
| H74939031553080 | 08714729757207 | 03-13-06 | F/G,STERLING,MR,5.5x30/80(4F) |
| H74939031554010 | 08714729757214 | 03-13-06 | F/G,STERLING,MR,5.5x40/135(4F) |
| H74939031554080 | 08714729757221 | 03-13-06 | F/G,STERLING,MR,5.5x40/80(4F) |
| H74939031556010 | 08714729859567 | 03-13-06 | FGSTERLINGMR,5.5mmx60mmx135cm(4F) |
| H74939031556080 | 08714729859574 | 03-13-06 | FGSTERLINGMR,5.5mmx60mmx80cm(4F) |
| H74939031601080 | 08714729757238 | 03-13-06 | F/G,STERLING,MR,6.0x10/80(4F) |
| H74939031601110 | 08714729859581 | 03-13-06 | FGSTERLINGMR,6.0mmx100mmx150cm(4F) |
| H74939031601190 | 08714729859598 | 03-13-06 | FGSTERLINGMR,6.0mmx100mmx90cm(4F) |
| H74939031601510 | 08714729859604 | 03-13-06 | FGSTERLINGMR,6.0mmx15mmx135cm(4F) |
| H74939031601580 | 08714729757245 | 03-13-06 | F/G,STERLING,MR,6.0x15/80(4F) |
| H74939031601610 | 08714729859611 | 03-13-06 | FGSTERLINGMR,6.0mmx150mmx150cm(4F) |
| H74939031601690 | 08714729859628 | 03-13-06 | FGSTERLINGMR,6.0mmx150mmx90cm(4F) |
| H74939031602010 | 08714729757252 | 03-13-06 | F/G,STERLING,MR,6.0x20/135(4F) |
| H74939031602080 | 08714729757269 | 03-13-06 | F/G,STERLING,MR,6.0x20/80(4F) |
| H74939031602110 | 08714729859635 | 03-13-06 | FGSTERLINGMR,6.0mmx200mmx150cm(4F) |
| H74939031602190 | 08714729859642 | 03-13-06 | FGSTERLINGMR,6.0mmx200mmx90cm(4F) |
| H74939031602210 | 08714729859659 | 03-13-06 | FGSTERLINGMR,6.0mmx220mmx150cm(4F) |
| H74939031602290 | 08714729859666 | 03-13-06 | FGSTERLINGMR,6.0mmx220mmx90cm(4F) |
| H74939031603010 | 08714729757276 | 03-13-06 | F/G,STERLING,MR,6.0x30/135(4F) |
| H74939031603080 | 08714729757283 | 03-13-06 | F/G,STERLING,MR,6.0x30/80(4F) |
| H74939031604010 | 08714729757290 | 03-13-06 | F/G,STERLING,MR,6.0x40/135(4F) |
| H74939031604080 | 08714729757306 | 03-13-06 | F/G,STERLING,MR,6.0x40/80(4F) |
| H74939031606010 | 08714729757313 | 03-13-06 | F/G,STERLING,MR,6.0x60/135(4F) |
| H74939031651110 | 08714729859673 | 03-13-06 | FGSTERLINGMR,6.5mmx100mmx150cm(4F) |
| H74939031651190 | 08714729859680 | 03-13-06 | FGSTERLINGMR,6.5mmx100mmx90cm(4F) |
| H74939031651510 | 08714729859697 | 03-13-06 | FGSTERLINGMR,6.5mmx15mmx135cm(4F) |
| H74939031651580 | 08714729757320 | 03-13-06 | F/G,STERLING,MR,6.5x15/80(4F) |
| H74939031651610 | 08714729859703 | 03-13-06 | FGSTERLINGMR,6.5mmx150mmx150cm(4F) |
| H74939031651690 | 08714729859710 | 03-13-06 | FGSTERLINGMR,6.5mmx150mmx90cm(4F) |
| H74939031652010 | 08714729757337 | 03-13-06 | F/G,STERLING,MR,6.5x20/135(4F) |
| H74939031652080 | 08714729757344 | 03-13-06 | F/G,STERLING,MR,6.5x20/80(4F) |
| H74939031652210 | 08714729859727 | 03-13-06 | FGSTERLINGMR,6.5mmx220mmx150cm(4F) |
| H74939031652290 | 08714729859734 | 03-13-06 | FGSTERLINGMR,6.5mmx220mmx90cm(4F) |
| H74939031653010 | 08714729757351 | 03-13-06 | F/G,STERLING,MR,6.5x30/135(4F) |
| H74939031653080 | 08714729757368 | 03-13-06 | F/G,STERLING,MR,6.5x30/80(4F) |
| H74939031654010 | 08714729757375 | 03-13-06 | F/G,STERLING,MR,6.5x40/135(4F) |
| H74939031654080 | 08714729757382 | 03-13-06 | F/G,STERLING,MR,6.5x40/80(4F) |
| H74939031656010 | 08714729859741 | 03-13-06 | FGSTERLINGMR,6.5mmx60mmx135cm(4F) |
| H74939031656080 | 08714729859758 | 03-13-06 | FGSTERLINGMR,6.5mmx60mmx80cm(4F) |
| H74939031701080 | 08714729757399 | 03-13-06 | F/G,STERLING,MR,7.0x10/80(4F) |
| H74939031701110 | 08714729859765 | 03-13-06 | FGSTERLINGMR,7.0mmx100mmx150cm(4F) |
| H74939031701190 | 08714729859772 | 03-13-06 | FGSTERLINGMR,7.0mmx100mmx90cm(4F) |
| H74939031701510 | 08714729859789 | 03-13-06 | FGSTERLINGMR,7.0mmx15mmx135cm(4F) |
| H74939031701580 | 08714729757405 | 03-13-06 | F/G,STERLING,MR,7.0x15/80(4F) |
| H74939031701610 | 08714729859796 | 03-13-06 | FGSTERLINGMR,7.0mmx150mmx150cm(4F) |
| H74939031701690 | 08714729859802 | 03-13-06 | FGSTERLINGMR,7.0mmx150mmx90cm(4F) |
| H74939031702010 | 08714729757412 | 03-13-06 | F/G,STERLING,MR,7.0x20/135(4F) |
| H74939031702080 | 08714729757429 | 03-13-06 | F/G,STERLING,MR,7.0x20/80(4F) |
| H74939031702110 | 08714729859819 | 03-13-06 | FGSTERLINGMR,7.0mmx200mmx150cm(4F) |
| H74939031702190 | 08714729859826 | 03-13-06 | FGSTERLINGMR,7.0mmx200mmx90cm(4F) |
| H74939031702210 | 08714729859833 | 03-13-06 | FGSTERLINGMR,7.0mmx220mmx150cm(4F) |
| H74939031702290 | 08714729859840 | 03-13-06 | FGSTERLINGMR,7.0mmx220mmx90cm(4F) |
| H74939031703010 | 08714729757566 | 03-13-06 | F/G,STERLING,MR,7.0x30/135(4F) |
| H74939031703080 | 08714729757436 | 03-13-06 | F/G,STERLING,MR,7.0x30/80(4F) |
| H74939031704010 | 08714729757443 | 03-13-06 | F/G,STERLING,MR,7.0x40/135(4F) |
| H74939031704080 | 08714729757450 | 03-13-06 | F/G,STERLING,MR,7.0x40/80(4F) |
| H74939031706010 | 08714729757467 | 03-13-06 | F/G,STERLING,MR,7.0x60/135(4F) |
| H74939031801080 | 08714729757474 | 03-13-06 | F/G,STERLING,MR,8.0x10/80(4F) |
| H74939031801580 | 08714729757481 | 03-13-06 | F/G,STERLING,MR,8.0x15/80(4F) |
| H74939031802010 | 08714729757498 | 03-13-06 | F/G,STERLING,MR,8.0x20/135(4F) |
| H74939031802080 | 08714729757504 | 03-13-06 | F/G,STERLING,MR,8.0x20/80(4F) |
| H74939031803010 | 08714729757511 | 03-13-06 | F/G,STERLING,MR,8.0x30/135(4F) |
| H74939031803080 | 08714729757528 | 03-13-06 | F/G,STERLING,MR,8.0x30/80(4F) |
| H74939031804010 | 08714729757535 | 03-13-06 | F/G,STERLING,MR,8.0x40/135(4F) |
| H74939031804080 | 08714729757542 | 03-13-06 | F/G,STERLING,MR,8.0x40/80(4F) |
| H74939031806010 | 08714729757559 | 03-13-06 | F/G,STERLING,MR,8.0x60/135(4F) |
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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