Find out who we are, explore careers at the company, and view our financial performance. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). If excessive force is felt during stent deployment, do not force the delivery system. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 4.8 F Stent Diameter, Device Size Text, specify: 24 cm Effective Length, Device Size Text, specify: 1.6 mm Stent Diameter. Data on File. Magnetic Resonance Imaging (MRI) | Boston Medical Center Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. One Boston Medical Center Place Do not expose the delivery system to organic solvents, e.g., alcohol. PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication. We are committed to providing the best experience possible for our patients and visitors. Store in a cool, dark, dry place. All other trademarks are the property of their respective owners. Find products, medical specialty information, and education opportunities. The delivery system is not designed for use with power injection systems. All stents should be deployed in accordance with the manufacturers indications and instructions for use. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Choose from Monorail and Over-the-Wire Catheter options. 170 subjects at 21 sites in the U.S., Europe, and Australia/New Zealand, * Evaluated against literature derived performance goal of 74% for efficacy (p<.0001) and 89% for safety (p=.032), 1The Venovo Venous Stent System was studied in the global VERNACULAR clinical trial, which was a prospective, multi-center, non-randomized, single-arm study of 170 patients. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Once in the scan room, the technologist will explain the exam before it begins and will give the patient ear plugs to muffle the noise the machine makes. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861720 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 2=[DE8m|E23 jIrL|bW30+;$12r+e5Jl+]pVIn[Ndck0xc$VVq+9e'0")m275ahsk8/` $4,,:8X3@$3h` u40y@p ` i;+:dXf`6@,ohH=`)35^7;7>n`pRwg 1hQb`br&Y' 6G A sales representive will get in touch with you shortly. Stents were evaluated at the 36-month follow-up for fracture analysis. Reusing this medical device bears the risk of cross-patient contamination as medical devices particularly those with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. Find out who we are, explore careers at the company, and view our financial performance. Data on file. THE List - MRI Safety Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. Staff also needs to know specific details about any implants in the body. endstream endobj startxref Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. GMDN Names and Definitions: Copyright GMDN Agency 2015. 44, no. This site is Exclusively Sponsored by BRACCO. Brand Name: Polaris Ultra Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729754565 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Ureteral Stent Polaris Ultra - Device Characteristics Polaris Ultra - GMDN
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