WAW SOFTWARE

Primary DI
05430003362280
Brand
WAW SOFTWARE
Company
Devroye Instruments Belgium
Model
V1.x.z
Device description
The WAW Duo FUE Product Line 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: - 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, intended to recharge the wireless handpiece and the slim handpiece. - The WAW Slim Handpiece is sold separately: 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 o Designed with a slimmer and lighter profile to enhance precision, smooth and ergonomic experience.
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
05430003362280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430003362280054300033622805430003362280

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 Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
372521769
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430003362112WAW SLIM HANDPIECE12026-09-21
05430003362242WAW CHARGING STATION32026-09-21
05430003362259WAW Duo FUE System22026-09-21
05430003362006WAW WIRELESS HANDPIECE22025-05-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430003362112WAW SLIM HANDPIECEDevroye Instruments BelgiumGEY2026-09-21
05430003362242WAW CHARGING STATIONDevroye Instruments BelgiumGEY2026-09-21
05430003362259WAW Duo FUE SystemDevroye Instruments BelgiumGEY2026-09-21
00889024712300Z1 POSTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
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05051471225541De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-01
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05051471223875De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-03
05051471223639De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-01
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
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