WebMar 29, 2024 · What MRI safety information does the labeling contain? MR Safe Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No Device labeled as "Not made with natural rubber latex": ... Polymeric biliary stent, non-bioabsorbable A sterile non-bioabsorbable tubular device intended to be … http://mrisafety.com/TMDL_list.php?goto=9
General Product Information Cook Medical
WebCook Medical adheres to the MR (magnetic resonance) safety terminology defined in ASTM International standard practice F2503-13. Where available, MR safety information can be found on each product specification page on the Cook Medical website. The three categories of MR safety marking are: MR Safe, MR Conditional, and MR Unsafe. WebThe stent's patented design balances strength and flexibility for proven patency as found in the VISIBILITY ILIAC study. Radiopaque markers on the stent ensure precise placement. Deliver over an 0.035" guidewire for use in the common or external iliac arteries or in the biliary system. Indications, Safety, and Warnings Product Details Back to top le winch café
Cotton-Huibregtse® Biliary Stent Sets Cook Medical
WebEase of Introduction. Glidex™ Hydrophilic Coating is intended to increase catheter lubricity to facilitate ease of insertion. R/O Marker, on the Flexima Biliary drainage Catheter with R/O, is intended to enhance catheter … WebMar 29, 2024 · GMDN Preferred Term Name. GMDN Definition. Polymeric biliary stent, non-bioabsorbable. A sterile non-bioabsorbable tubular device intended to be implanted … Web8. The safety and effectiveness of the device have not been evaluated in subjects with the following conditions: a. Primary or extensive metastatic hepatic malignancy. b. Polycystic liver disease. c. Budd-Chiari syndrome. d. Severe or rapidly progressive hepatic failure. e. Unrelieved biliary obstruction. lewin charcot