Boston Scientific Corporation

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Description

148 dispositivos en la base de datos

  • Modelo / Serial
    Lot/Batch No.  57271 57616 57269 and 57613.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (AL, AZ, AR, CA, CO,CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VT, VA, WA, WV and WI), United Arab Emir., Dutch Antilles, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Israel, Italy, South Korea, Kuwait, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Puerto Rico, Portugal, Qatar, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, and South Africa.
  • Descripción del producto
    Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: || Product Description and Material/UPN/Catalog Number || Imager" II Catheters C2, 5Fr, 65cm M0064003010 (inner pouch) || M0064003011 (outer box); || Imager" II Catheters Straight, 5Fr, 65cm M0064003020 (inner pouch) || M0064003021 (outer box) and || Imager" II Catheters Bern, 5Fr, 65cm M0064003030 (inner pouch) || M0064003031 (outer box) || The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steal braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.
  • Modelo / Serial
    Lot/Batch 57139 57392 57709 57248 57533 57258 57263 57612 57242 57243 57510 57530 57531 57173 57296 57297 57381 57534 57535 57238 57389 57697 57383 57130 57265 57245 57214 57266 57298 57784 57120 57617 57621 57128 57708 57244 57783 57382 57119 57695 57698 57133 57696 57580 57247 57135 57123 57782 57134 57268 57388 57369 57124 57600 57419 57278 57283 57699 57233 57414 57415 57225 57528 57409 57410 57282 57587 57403 57404 57583 57044 57045 57046 57090 57275 57581 57582 57588 57279 57586 57706 57375 57215 57602 57603 57608 57578 57579 57376 57526 57527 57577 and 57378.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (AL, AZ, AR, CA, CO,CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VT, VA, WA, WV and WI), United Arab Emir., Dutch Antilles, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Israel, Italy, South Korea, Kuwait, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Puerto Rico, Portugal, Qatar, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, and South Africa.
  • Descripción del producto
    Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: || Material Number (OUTER CARTON LABEL OF 5pk) /Material Number (INNER-POUCH LAB LE FOR EACH SINGLE CATHETER)/ Catalog Number /Material Description: || M001314001 M001314000 31-400 IMAGER II/5/ST/65/038 BX5; || M001314021 M001314020 31-402 IMAGER II/5/ST/65/035 BX 5; || M001314071 M001314070 31-407 IMAGER II/5/BERN/40/035 BX 5; || M001314081 M001314080 31-408 IMAGER II/5/BERN/40/038 BX5; || M001314091 M001314090 31-409 IMAGER II/5/BERN/65/035 BX 5; || M001314101 M001314100 31-410 IMAGER II/5/BERN/65/038 BX5; || M001314301 M001314300 31-430 IMAGER II/5/SIM1/65/038 BX5; || M001314521 M001314520 31-452 IMAGER II/5/CHGB/65/038 BX5; || M001314561 M001314560 31-456 IMAGER II/5/CHG2.5/65/038 BX5; || M001314571 M001314570 31-457 IMAGER II/5/CHG2.5/65/035 BX 5; || M001314581 M001314580 31-458 IMAGER II/5/CONTRA 2/65/038 BX5; || M001314591 M001314590 31-459 IMAGER II/5/CONTRA 2/65/035 BX 5; || M001314611 M001314610 31-461 IMAGER II/5/DUCK/65/035 BX 5; || M001314661 M001314660 31-466 IMAGER II/5/C2/65/038 BX5; || M001314671 M001314670 31-467 IMAGER II/5/C2/65/035 BX 5; || M001314681 M001314680 31-468 IMAGER II/5/C2+2 SIDE HOLES/65/038 BX5; || M001314691 M001314690 31-469 IMAGER II/5/C2+2 SIDE HOLES/65/035 BX 5; || M001314751 M001314750 31-475 IMAGER II/5/TRAIN/65/038 BX5; || M001314761 M001314760 31-476 IMAGER II/5/MIK/65/038 BX5; || M001314791 M001314790 31-479 IMAGER II/5/HK1.0/65/035 BX 5; || M001314801 M001314800 31-480 IMAGER II/5/SHK0.8/65/038 BX5; || M001314811 M001314810 31-481 IMAGER II/5/SHK0.8/65/035 BX 5; || M001314821 M001314820 31-482 IMAGER II/5/SHK1.0/65/038 BX5; || M001314851 M001314850 31-485 IMAGER II/5/RC1/65/035 BX 5; || M001314861 M001314860 31-486 IMAGER II/5/RC2/65/038 BX5; || M001314881 M001314880 31-488 IMAGER II/5/RDC/65/038 BX5; || M001314891 M001314890 31-489 IMAGER II/5/RDC/65/035 BX 5 and || M001314911 M001314910 31-49I IMAGER II/5/RDC+2 SIDEHOLES/65/035 BX 5: || M001315001 M001315000 31-500 IMAGER II/4/TENNIS RACQUET/65/035 BX5; || M001315031 M001315030 31-503 IMAGER II/5/TENNIS RACQUET/65/035 BX5; || M001315061 M001315060 31-506 IMAGER II/5/TENNIS RACQUET/65/038 BX5; || M001315091 M001315090 31-509 IMAGER II/4/PIGTAIL/65/035 BX5; || M001315101 M001315100 31-510 IMAGER II/4/STRAIGHT/65/035 BX5; || M001315131 M001315130 31-513 IMAGER II/5/PIGTAIL/65/038 BX5; || M001315161 M001315160 31-516 IMAGER II/5/STAIGHT/65/038 BX5; || M001315191 M001315190 31-519 IMAGER II/5/PIGTAIL/65/035 BX5; || M001315201 M001315200 31-520 IMAGER II/5/STRAIGHT/65/035 BX5; || M001315251 M001315250 31-525 IMAGER /4/CONTRALATERAL/65/035 BX5; || M001315281 M001315280 31-528IMAGER II/5/CONTRALATERAL/65/035 BX5; || M001315311 M001315310 31-531 IMAGER II/5/CONTRALATERAL/65/038 BX5; || M001316021 M001316020 31-602 MODEL-IMAGER II/ 4/ ST/65/035; || M001316071 M001316070 31-607 MODEL-IMAGER II/ 4/ BERN/40/035; || M001316091 M001316090 31-609 MODEL-IMAGER II/ 4/ BERN/65/035; || M001316311 M001316310 31-631 MODEL-IMAGER II/ 4/ SIM1/65/035; || M001316531 M001316530 31-653 MODEL-IMAGER II/ 4/ CHGB/65/035; || M001316551 M001316550 31-655 MODEL-IMAGER II/ 4/ CHGC/65/035; || M001316581 M001316580 31-658 MODEL-IMAGER II/ 4/ CONTRA 2/65/035; || M001316691 M001316690 31-669 MODEL-IMAGER II/4/C2+2 SIDE HOLES/65/035 and || M001316851 M001316850 31-685 MODEL-IMAGER II/ 4/ RC1/65/035. || Imager " II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with
  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution -- United States including Puerto Rico.
  • Descripción del producto
    Boston Scientific Liberte¿¿ Monorail¿ and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". || The Liberte¿¿ Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte¿ Monorail¿ (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte¿ system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.
  • Modelo / Serial
    11520769
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution --- including states of AL, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE , NV, NH, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and PR.
  • Descripción del producto
    Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-460, UPN M001434601, Sterilized with ethylene oxide gas. UPN for inner pouch M001434600. || M001434601 || 43-460 || Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
  • Modelo / Serial
    11518343, 11535832, and  11634771
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution --- including states of AL, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE , NV, NH, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and PR.
  • Descripción del producto
    Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-459, UPN M001434591, Sterilized with ethylene oxide gas. UPN for inner pouch M001434590. || Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
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Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    TDMDAT
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    AMPMDC
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