Product was released for distribution to 38 consignees in US nationwide. International distribution includes EU and Canada. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.
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Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, || Catalog/Model Numbers: 8200010, 8200TWA0
Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.
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Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: || The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. || 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. || 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F.
Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.
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Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: || 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 || 2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015 || The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: " Discrete (< 15 mm in length), or tubular (10 to 20 mm in length) " Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm " Readily accessible to the device " Light to moderate tortuosity of proximal vessel segment " Nonangulated lesion segment (< 45¿) " Smooth angiographic contour " Absence of angiographically visible thrombus and/or calcification.
Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and Venezuela.
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Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and Venezuela.
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Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.
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TWISTER PLUS 22mm Rotatable || Retrieval Device (Box of 5 configuration) || Universal Product Number (UPN): M00561411. || Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. || Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.