39d5df3a-2cdc-4a1a-80e9-3854fc70952dUpdatePublished72021-12-222015-10-09In Commercial Distribution00836462002142PrimaryGS1Rebar105-5080-153C105-5080-153C826110710Micro Therapeutics, Inc.114 Micro CatheterfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(508)261-8000covidien.udi@covidien.comK09375000017846Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.falseActiveKRACatheter, continuous flushLengthDevice Size Text, specifyDistal OD,1.9,French;Proximal OD,2.4,French;Storage Environment TemperatureSpecial Storage Condition, SpecifyKeep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHTtruefalse