WAW Duo FUE System

Organization name

Devroye Instruments SRL

SRN

BE-MF-000034423

Manufacturer status

Active

Primary placement in Belgium; available across 15 countries total.

Trade name

not provided

UDI-DI code

05430003362044

Basic UDI-DI

54300033620WDFSystem69

Reference / catalog number

WAW Duo FUE System

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• L0318INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE

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