Device typeUrethral dilatation catheter, non-medicated: A sterile, flexible or semi-flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage. The device is typically made of plastic and silicone materials and is available in a variety of designs whereby: 1) it may have a larger diameter than that of a normal urethra; 2) it may have an attached inflatable balloon; or 3) the leading end of the device may be moulded into an extremely slender or thread-shaped form in order to facilitate passage of a larger, following portion; it does not elute a drug. This is a single-use device.
FDA categoryDilator, Urethral
Device ID00840217910002
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information