WAW PEDAL

GUDID 05430003362020

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: - 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 External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.

Devroye Instruments Belgium

Electrosurgical handpiece, reusable

• Primary Device ID: 05430003362020
• NIH Device Record Key: 03694cb5-e7ec-40d0-ac6a-8cd18a14068f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAW PEDAL
• Version Model Number: 1
• Company DUNS: 372521769
• Company Name: Devroye Instruments Belgium
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com
• Phone: +3208807064
• Email: info@devroyeinstruments.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430003362020 [Primary]

FDA Product Code

• GEY: Motor, Surgical Instrument, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-19
• Device Publish Date: 2025-05-09

Devices Manufactured by Devroye Instruments Belgium

• 05430003362006 - WAW WIRELESS HANDPIECE: 2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
• 05430003362013 - WAW WIRED HANDPIECE: 2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
• 05430003362020 - WAW PEDAL: 2025-05-19The 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: - 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 External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
• 05430003362020 - WAW PEDAL: 2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
• 05430003362037 - WAW CHARGING STATION: 2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
• 05430003362044 - WAW Duo FUE System: 2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
• 05430003362051 - EXTERNAL SLEEVE SUPPORT BOX: 2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
• 05430003362068 - WAW SOFTWARE: 2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
• 05430003362075 - WAW HYBRID TORNADO Schambach PUNCH 1.00: 2025-05-19 The WAW Hybrid Tornado Punch is a single use medical device intended to prepare follicular units for extraction from a patient's