Bioseal Inc.

Device typeFibreoptic vaginal speculum: A hand-held manual metallic instrument intended to dilate and illuminate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. The device includes an integrated fibreoptic bundle to transmit light from an electric light source to enhance visualization. This is a reusable device.

FDA categorySpeculum, vaginal, nonmetal, fiberoptic

Device ID00630094689012

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information