Details
Device typeUterine manipulator, single-use: A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.
FDA categoryCannula, Manipulator/Injector, Uterine
Device ID09349967003114
AvailabilityPrescription
Single useYes
SterileYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information
Outer Diameter32 Millimeter