INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE

Primary DI

05430003362044

Basic UDI-DI Code

54300033620WDFSystem69

Reference

WAW Duo FUE System

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Devroye Instruments SRL

The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect to naturalness and density) and the donor (taking care of the donor region). The WAW Duo FUE System is composed of the following (illustrated in Figure 1): - The WAW Wireless Handpiece: o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external sleeve o Connected via Bluetooth to the tablet o Responsible for the rotation and oscillation movements of the punch (not included) for the FUE, - The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece: o Cleanable (via autoclave) o Connected via a wire to the pedal o Responsible for the rotation and oscillation movements of the punch for the FUE, - The WAW Pedal, responsible for activating the handpieces, - The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied), - The WAW Charging Station (Figure 2), intended to recharge the wireless handpiece and - The External Sleeve Support Box (Figure 3), intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process.

The Basic UDI-DI associated with this device has 6 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).