WAW WIRELESS HANDPIECE

Primary DI
05430003362006
Brand
WAW WIRELESS HANDPIECE
Company
Devroye Instruments Belgium
Model
2
Device description
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair folliclesby preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. Thisis done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respectto naturalness and density) and the donor (taking care of the donor region).The WAW Duo FUE System is composed of the following:- The WAW Wireless Handpiece:o Composed of a motor and a battery, and a detachable cleanable (via autoclave) externalsleeveo Connected via Bluetooth to the tableto Responsible for the rotation and oscillation movements of the punch (not included) for theFUE,- The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece:o Cleanable (via autoclave)o Connected via a wire to the pedalo 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 andoscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of thepedal (the Samsung tablet is supplied),- The WAW Charging Station, intended to recharge the wireless handpiece and- The External Sleeve Support Box, intended to sustain external parts of WAW WirelessHandpiece and WAW Wired Handpiece during autoclave process.- Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Published
2025-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430003362006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430003362006054300033620065430003362006

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal105 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal105 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3208807064info@devroyeinstruments.com

Regulatory Flags#

DUNS number
372521769
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430003362013WAW WIRED HANDPIECE12025-05-09
05430003362020WAW PEDAL12025-05-09
05430003362037WAW CHARGING STATION22025-05-09
05430003362044WAW Duo FUE System12025-05-09
05430003362051EXTERNAL SLEEVE SUPPORT BOX12025-05-09
05430003362068WAW SOFTWARE0.1.352025-05-09
05430003362075WAW HYBRID TORNADO Schambach PUNCH 1.001.00LH25082025-05-09
05430003362129WAW HYBRID TORNADO PUNCH 0.850.8525082025-05-09
05430003362136WAW HYBRID TORNADO PUNCH 0.900.9025082025-05-09
05430003362143WAW HYBRID TORNADO PUNCH 0.950.9525082025-05-09
05430003362150WAW HYBRID TORNADO PUNCH 1.001.0025082025-05-09
05430003362167WAW HYBRID TORNADO PUNCH 1.051.0525082025-05-09
05430003362174WAW HYBRID TORNADO PUNCH 1.101.1025082025-05-09
05430003362181WAW HYBRID TORNADO PUNCH 1.201.2025082025-05-09
05430003362198WAW HYBRID TORNADO Schambach PUNCH1.00LH24072025-05-09
05430003362204WAW HYBRID TORNADO PUNCH 0.800.8025082025-05-09
05430003362228PUNCH SUPPORT BOX12025-05-09

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