b31bb289-f17e-42eb-a8b9-de9bfa94ddcfUpdatePublished52025-11-032016-09-24In Commercial Distribution08714729005490PrimaryGS1NAM0062601070021717889BOSTON SCIENTIFIC CORPORATION1Amplatz Type Renal DilatorfalsetruefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse38821Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.falseActiveGCCDilator, catheterDevice Size Text, specify35 cm LengthDevice Size Text, specify6.8 mm DiameterDevice Size Text, specify20 F Diametertruefalse