The WAW Hybrid Tornado Punch is a single use medical device intended to prepare follicular units for extraction from a patient's body, as part of a hair transplantation procedure. This is done by coring the tissues included in the hair follicle to separate them from the surrounding tissues. The movement of the WAW Hybrid Tornado Punch is intended to be provided by its accessory, the WAW Duo FUE System active device. The punch is intended to be used with the WAW Duo FUE System. More specifically, the punch is intended to be mounted on the handpiece of the system. It is inserted in the handpiece extremity during the FUE procedure. The punch is compatible with both handpieces of the system (wired and wireless). The device is invasive and sterilizable (autoclave), but not reusable. The device is intended to be sterilized by the user before use. A maximum of two devices can be used during a single procedure. The WAW Hybrid Tornado Punch is available in 8 different diameters ranging from 0.8 to 1.2 mm. The choice of punch depends on the number of hairs per graft, the thickness of the hairs and how close they are to each other. Additionally, the Hybrid Tornado Schambach Notches Punch is an extra model with 4 notches on the toothed part specifically designed for extracting long hair (Long Hair FUE). It comes in a single diameter of 1.0 mm, in two different materials (two different types of stainless steel).
A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device.
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