WAW Duo FUE System

Nom de l'organisation

Devroye Instruments SRL

SRN

BE-MF-000034423

Statut du fabricant

Actif

Marché principal en Belgique ; disponible dans 15 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05430003362044

Basic UDI-DI

54300033620WDFSystem69

Numéro de référence/catalogue

WAW Duo FUE System

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• L0318INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel