More Information. Olympus stent types includes dual- and single-durometer, Tecoflex®, and silicone—each with a selection of curl designs, tip configurations . In these investigations, AMS products underwent evaluations for magnetic field interactions at 1.5 and/or 3.0 . GMDN Definition. Facility Maintenance & Safety Personal Protective Equip/PPE; First Aid Bandages, Gauze & Dressings; Home Care. Polyurethane Catheter. ORDER SIZE BALLOON EYES LENGTH QTY 186005* cylindrical Ch. Magnetic Resonance Imaging (MRI) The Precision Montage MRI SCS System with ImageReady MRI Technology is "MRI-Conditional" only when exposed to the MRI environment under the specific conditions defined in the ImageReady™ MRI Full Body Guidelines for Precision . [6,20] Despite the fact that initial mid-term results of their use on malignant strictures were promising (five out of six stents remained patent without additional . [DOI LINK] Boston Scientific. Object Status Safe. Coils, Filters, Stents, and Grafts More. MRI safety Status: MR Conditional: Device required to be labeled as containing natural rubber latex or dry . Stents are basically small tubes or sometimes springs that help prop arteries open. +1 (415)683-7878. UPC: Current Stock: This item is out of stock. Polymeric ureteral stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain . 6Fr X 26Mm Ureteral Ascerta Stent. Boston Scientific has been recognized with a Bronze Edison Award in the Science & Medical category for its Tria™ Ureteral Stent, the first stent made with a proprietary surface. Polymeric ureteral stent. The stent emits paclitaxel, a drug intended to inhibit restenosis caused by scar tissue growth. Close ×. (5) Ahmed S, Shellock FG. J Endourol 2010;24:483-485. A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. Metal stents for the . Ascerta Ureteral Stent - 7Fr x 28cm Boston Scientific $20.00) Model #: 145 . Boston Scientific Ascerta Ureteral Stent - 4.8Fr x 28cm: 4.8Fr x 28cm $10.00. EMBLEM™ MRI S-ICD System; GreenLight™ Laser Therapy; . (1.6 mm x 220 mm) Microvasive Boston Scientific Corporation Watertown, MA. Magnetic resonance imaging device for tracking medical instruments AU779202B2 (en) . The remaining authors declare that the research was conducted in the absence of any commercial or financial . support@graylinemedical.com. Skip to the end of the images gallery. Read More ». /Each. 0000006770 . Tapered tip designed to help facilitate ease of access through the ureteral orifice. 6 Placement Stiff during placement designed to navigate patient anatomy. Advanix Pancreatic Stent Kit - Single Pigtail Stent w- Leading Barb - 5Fr x 9cm. Offering a broad portfolio of firm, soft and dual-durometer ureteral stents designed to accommodate your patient's anatomy, clinical presentation and personal tolerance. The bladder is inspected, and the ureteric opening is located. UPC: Current Stock: This item is out of stock. GMDN Definition. This ureteric stent from Boston Scientific is de signed with high retention coil strength to help maintain pigtail shape and prevent stent migration. . Qty . This item may require 5-7 days to ship out from our facility. 5Fr x 9cm. GMDN Preferred Term Name. Product Details Design Features Material strength and smooth stent surface facilitate navigation of tight strictures Graduated circumferential markings every 5cm along the body of the stent Low profile stent with larger inner lumen for improved ID/OD ratio Designed to reduce risk of migration due to high retention coil strength Boston Scientific. GMDN Preferred Term Name GMDN Definition; Polymeric ureteral stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. Advanix Pancreatic Stent Kit - Single Pigtail Stent w- Leading Barb - 7Fr x 12cm. Stent - Double pigtail, radiopaque black silicone. In these investigations, AMS products underwent evaluations for magnetic field interactions at 1.5 and/or 3.0 . 0000002525 00000 n 0000194891 00000 n 032148 Global Unique Device ID: 08714729787402. Specialist, Regulatory Affairs NATICK, Mass., March 22, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the U.S. and international launch of the WallFlex ® Biliary Transhepatic Stent System. Proprietary co-extrusion technology allows the stent to be firm in the kidney and soft in the bladder - creating a seamless transition from firm to soft so you can promote patient tolerance1,2 Up to 365-day indwell time4 Placement A tapered renal tip designed for ease of stent placement and removal5 Cook Medical adheres to the MR (magnetic resonance) safety terminology defined in ASTM International standard practice F2503-13. $29.00. The procedure is usually performed with the patient asleep (under general anaesthesia). Boston Scientific Corp Matt Beauchane Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566 Re: K141344 Trade/Device Name: Expel™ Nephroureteral Drainage Stent With Twist-Loc Hub System Expel™ Ureteral Drainage Stent System Regulation Number: 21 CFR 876.4620 Regulation Name: Uretal Stent Regulatory Class: Class II . Labeling does not contain MRI Safety Information . Lot 8473180. Nephrostomy catheter. 1. Magnetic resonance imaging (MRI) . The ureters are part of the urinary system. Less bladder irritation.1 This dual-durometer stent features two unique bladder loops that result in an average of 69% less material in your patient's bladder than a traditional stent. Variable Length coils on distal and proximal ends allow for one stent to fit various ureteral lengths. HydroPlus Coating to facilitate advancement Bladder markings to confirm placement Multiple Sizes Fixed Length Stent 6F - 8F with lengths ranging from 20cm - 30cm Variable Length Stent 4.8F - 7F with lengths of 22 - 30cm Latex Information Refer to "Stent Deployment Procedure, Section 4. It is generally safe to undergo magnetic resonance imaging ( MRI) scans with stents in place, though a lot of this depends on when the stent was implanted and what, exactly, it is intended to do. Manufacturer. (4) Levine GN, et al. Amalgamators; Burs & Bur Blocks; Curing-Light; . Biocompatible material designed to enable indwell time up to 365 days. Email Me When In . Ascerta Firm Ureteral Stent - 4.8Fr x 30cm Boston Scientific. 1. Rating Required Select Rating 1 star (worst) 2 stars 3 stars (average) 4 stars 5 stars (best) Name Required. . Skip to the beginning of the images gallery. Amplatz Ureteral Stents are not intended to remain . Apr 15, 2021. manufacturers: Cook Medical Resonance® Metallic Ureteral Stent, Boston Scientific Percuflex® Ureteral Stent, and Bard InLay® Ureteral Stent, respectively. Our Actions to Support Ukraine Humanitarian Relief Efforts. Boston Scientific named a Top 10 Best Employer for Diversity in 2021. MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Variable length coils on distal and proximal ends, so 1 stent can . Ureteral Stent, 4.8 Fr dia. Polaris™ Ultra - GMDN. $20.00) Model #: 145-621 OEM: Boston Scientific Year: 2018 Size: 7Fr x 28cm . Safety Topic / Subject Penile Implant Titan Inflatable Penile Prosthesis Model 90-98ICOTR MP35N, Urethane, silicone, Polysulfone Coloplast Corporation . April 22, 2022 Boston Scientific has been recognized with a Bronze Edison Award in the Science & Medical category for its Tria™ Ureteral Stent, the first stent made with a proprietary surface technology designed to provide protection against the accumulation of both urine calcium and magnesium salt deposits. Relaxed renal coil designed to facilitate ease of removal Biocompatible material designed for 365-day indwelling . Straight safety wire guide - Stainless steel, hydrophilic-coated, 0.038 inch (0.97 mm) diameter, 145 cm long, with filiform flexible tip. Graduated circumferential markings every 5 cm along the body of the stent for accurate placement. Description. Polaris™ Ultra - GMDN. Reference Part Number. Boston Scientific M0061456440 Ascerta Firm Ureteral Stent 4.8F x 30cm . A .035-inch hydrophilic wire (Radifocus, Terumo) was inserted into the urinary bladder and exchanged with a stiff guidewire (Amplatz Super Stiff, Boston Scientific) for antegrade ureteral stent insertion. Vascular Access Systems Division. Conclusions: . Bloomington, Ind. Advanix Biliary Stent 7Fr center bend, double pig tail, and duodenal bend. Innovative interface platforms available in the market for stent case management and patient safety are useful . Circulation 2007;116:2878-2891. 3731. GMDN Definition. The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. Deploy Stent" for directions on deploying the stent with the: AccessGUDID - Ascerta™ Firm (08714729861768)- Ureteral Stent. 2,3 Urology Polaris™ Ultra Ureteral Stent Firm where it needs to be. They will work with you to find the right fit and to let you know which new product codes you need to order. Magnetic Resonance Imaging (MRI) The Precision Montage MRI SCS System with ImageReady MRI Technology is "MRI-Conditional" only when exposed to the MRI environment under the specific conditions defined in the ImageReady™ MRI Full Body Guidelines for Precision . Chat with us! Access our instructions for use and product manuals library. Contact Christine Shoemaker Sr. Boston Scientific ranked eighth overall and first among companies in the Health Care Equipment and Services industry in the 2021 list of America's Best Employers for Diversity by Forbes. Apr 13, 2022 . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. GMDN Preferred Term Name. Strength 3.0. Contour Ureteral Stents. More Information. Order Number. Enabling rapid innovation. 1.5,3: Safe More. [i] (You save ) Write a Review. Tria™ Firm Ureteral Stent Boston Scientific K163399 SECTION 5 510(k) SUMMARY 510(k) Summary - Page 1 of 3 510(k) Summary for Tria™ Firm Ureteral Stent A. Deltec, Inc. St. Paul, M. Percuflex Plus Ureteral Stent With Hydro Plus Coating Boston Scientific Corporation Marlborough, MA Ureteral stents are thin, flexible tubes, used to restore urine flow through blocked ureters due to various disorders.
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