A	FDA	C106039	FDA CDRH GUDID Terminology	C223361	Safety in MRI Not Evaluated		For passive implants, passive medical devices that are fastened to or carried by a patient, and passive medical devices anticipated for use in the MR environment that have historically not provided any information about MRI safety, the following labeling could be used in certain circumstances. The medical device has not been evaluated for safety in the MR environment if 1) it has not been tested for heating or unwanted movement in the MR environment; 2) the safety of medical device in the MR environment is unknown; or 3) performing an MR exam on a person who has this medical device may result in injury or device malfunction. See Guidance for Industry: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.	The medical device has not been evaluated for safety in the MR environment under certain conditions.
C	FDA	C106039	FDA CDRH GUDID Terminology	C150146	Balloon Length	Nominal Length	The nominal length of the balloon per manufacturer specification.	The nominal length of the balloon per manufacturer specification.