Device typeProstate immobilization balloon catheter: A non-sterile flexible tube with an inflatable balloon at its distal end intended to be inserted into the rectum to facilitate adequate positioning and immobilization of the prostate during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. This is a single-use device.
FDA categoryProstate immobilizer rectal balloon
Device ID08719326258256
Single useYes
MRI safetyLabeling does not contain MRI Safety Information