Object Status Safe. Boston Scientific. Olympus offers the largest selection of ureteral stents on the market, each ensuring the highest standards of quality and performance. Liatsikos EN, Karnabatidis D, Katsanos K, et al. [DOI LINK] - Cook Medical has been awarded an interventional urology contract with Vizient, Inc., the largest healthcare performance improvement company in the United States. Cook Medical adheres to the MR (magnetic resonance) safety terminology defined in ASTM International standard practice F2503-13. reg. Boston Scientific M0061456440 Ascerta Firm Ureteral Stent 4.8F x 30cm . Prior to deployment, the shipping lock (8) must be removed and discarded. Used for internal drainage of urine. Specialist, Regulatory Affairs 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. 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 . FIND INSTRUCTIONS FOR USE MR-Conditional Device Information 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 . Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Facility Maintenance & Safety Personal Protective Equip/PPE; First Aid Bandages, Gauze & Dressings; Home Care. Product Information: Percuflex Plus Ureteral Stent, 6 Fr x 24 cm. Polyurethane Catheter. Safety of magnetic resonance imaging in patients with cardiovascular devices: An American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization. At Boston Scientific, our priority is to protect and aid the . Conclusions: . Constructed with Soft Percuflex Material that becomes soft at body temperature promoting patient tolerance of an indwelling stent. Give us a call! . Tapered tip designed to help facilitate ease of access through the ureteral orifice. Add. The remaining authors declare that the research was conducted in the absence of any commercial or financial . Stent positioner - Radiolucent vinyl. [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 . +1 (415)683-7878. AccessGUDID - Polaris Ultra (08714729124344)- Ureteral Stent. Order Number. 1.5,3: Safe More. GMDN Preferred Term Name. Based on experience with intravesical instillations with ketorolac for stent symptoms , a ketorolac-eluting stent was designed (Lexington stent, Boston Scientific, MA, USA). 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. 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. The procedure is usually performed with the patient asleep (under general anaesthesia). Graduated circumferential markings every 5 cm along the body of the stent for accurate placement. GMDN Preferred Term Name. Polaris Ultra - GMDN. Email us! 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. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. If stent placement had to be repeated immediately, an angiocatheter (RC1, Cook) was advanced over the safety guidewire into the renal pelvis. 4 TRANSURETHRAL FOLEY CATHETERS sIlAsIl Latex Silicone REF. Biocompatible material designed to enable indwell time up to 365 days. 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 . PORT-A-CATH II Dual-Lumen. The Inlay ureteral stent offers many advantages. $29.00. Manufacturer Part # M0061752620. MRI safety Status: MR Conditional: Device required to be labeled as containing natural rubber latex or dry . Sponsor Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01756 B. We recommend ureteral stent placement as the preferred intervention if local factors allow. Amplatz Ureteral Stents are not intended to remain . UPC: Current Stock: This item is out of stock. Ascerta Ureteral Stent - 7Fr x 28cm Boston Scientific $20.00) Model #: 145 . . Instructions. GMDN Definition. Object Category Coils, Filters, Stents, and Grafts. Unintended stent movement during sheath retraction is restricted by the delivery system. 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. Two balloon-expandable stents have been tested in human, the Strecker stent (Boston Scientific, Natick, MA, USA) and the Palmaz-Schatz (Johnson and Johnson, Warren, USA). Circulation 2007;116:2878-2891. Polaris Ultra - GMDN. The most comprehensive information guide on Expel Ureteral Stent System - BOSTON SCIENTIFIC CORPORATION including impacted physicians & ROI, Business Case, HEOR & VAC Business & Quality Metrics. Polymeric ureteral stent. 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. Stents are basically small tubes or sometimes springs that help prop arteries open. Boston Scientific Ascerta Ureteral Stent - 4.8Fr x 28cm: 4.8Fr x 28cm $10.00. $40.00. Percuflex Ureteral Stent Boston Scientific Corporation Marlborough, MA. 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. 5Fr x 9cm. The stent features a braided tether and graduation marks. A tube with a tiny optic camera is inserted through the urethra into your bladder. . Labeling does not contain MRI Safety Information . Nephrostomy catheter. The stent is intended as a palliative treatment of malignant neoplasms . Advanix Pancreatic Stent Kit - Single Pigtail Stent w- Leading Barb - 7Fr x 12cm. For Healthcare Professionals. Refer to "Stent Deployment Procedure, Section 4. $20.00) Model #: 145-644 OEM: Boston Scientific Year: 2018 Size: 4.8Fr x 30cm . 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 Amalgamators; Burs & Bur Blocks; Curing-Light; . Enabling rapid innovation. 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. Vascular Access Systems Division. Magnetic resonance imaging device for tracking medical instruments AU779202B2 (en) . Catheter, Suprapubic/Cystoscopic . 40 cm 10 Universa; Soft Ureteral Stent Set. Manufacturer: Boston Scientific. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. Straight safety wire guide - Stainless steel, hydrophilic-coated, 0.038 inch (0.97 mm) diameter, 145 cm long, with filiform flexible tip. Magnetic resonance imaging safety: Implications for . 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 More Information. 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. The bladder is inspected, and the ureteric opening is located. For Healthcare Professionals. Offering a broad portfolio of firm, soft and dual-durometer ureteral stents designed to accommodate your patient's anatomy, clinical presentation and personal tolerance. Polaris Ultra Ureteral Stent Boston Scientific Corporation www.bostonscientific.com The stent emits paclitaxel, a drug intended to inhibit restenosis caused by scar tissue growth. Polymeric ureteral stent. Polaris Loop Ureteral Stent Proprietary loop design. Sign up to receive clinical studies It has a high ID/OD ratio and larger inner lumen to facilitate drainage and patency. 1 Multiple Sizes Offered in both soft and firm stent durometers 4.8F - 8F diameter with lengths ranging from 10cm - 30cm Ordering Information View Ordering Information Reimbursement Increasing patient safety. MRI Information Several Magnetic Resonance Imaging (MRI) studies have concluded that the AMS products listed below will not produce additional risks to patients in association with MRI procedures under the conditions used for testing. Description. Large-bore, thin-walled tube with dissolving tip helps perform drainage for relief of supravesicular obstructions as well as variety of procedures of upper urinary tract.
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