ALLURA®

Device typePolymeric vaginal stent, non-bioabsorbable: A sterile non-bioabsorbable tubular device intended for long-term placement in the vagina to provide structural support and/or prevent shrinking. It is typically used for vaginal dilation following surgical or non-surgical treatment of vaginal agenesis or transgender vaginoplasty, or for the prevention of vaginal contracture or stenosis after radiotherapy. It is made of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., inflatable tubular envelope with valves and internal drains, semi-soft moulded tube). This is a single-patient use device that can be reapplied to the patient during the treatment period (e.g., nightly) before being discarded (reusable).

FDA categoryStent, Vaginal

Device ID00650551003229

AvailabilityPrescription

Single useYes

SterileYes

LatexNot made with natural rubber latex

MRI safetyLabeling does not contain MRI Safety Information