WAW HYBRID TORNADO Schambach PUNCH

GUDID 05430003362198

The WAW Hybrid Tornado Punch is a single use medical device intended to prepare follicular units for extraction from a patient's body, as part of a hair transplantation procedure. This is done by coring the tissues included in the hair follicle to separate them from the surrounding tissues. The movement of the WAW Hybrid Tornado Punch is intended to be provided by its accessory, the WAW Duo FUE System active device. The punch is intended to be used with the WAW Duo FUE System. More specifically, the punch is intended to be mounted on the handpiece of the system. It is inserted in the handpiece extremity during the FUE procedure. The punch is compatible with both handpieces of the system (wired and wireless). The device is invasive and sterilizable (autoclave), but not reusable. The device is intended to be sterilized by the user before use. A maximum of two devices can be used during a single procedure. The WAW Hybrid Tornado Punch is available in 8 different diameters ranging from 0.8 to 1.2 mm. The choice of punch depends on the number of hairs per graft, the thickness of the hairs and how close they are to each other. Additionally, the Hybrid Tornado Schambach Notches Punch is an extra model with 4 notches on the toothed part specifically designed for extracting long hair (Long Hair FUE). It comes in a single diameter of 1.0 mm, in two different materials (two different types of stainless steel).

Devroye Instruments Belgium

Hair extraction punch
Primary Device ID05430003362198
NIH Device Record Key584b0364-ebdc-4517-a485-e59138f33890
Commercial Distribution StatusIn Commercial Distribution
Brand NameWAW HYBRID TORNADO Schambach PUNCH
Version Model Number1.00LH2407
Company DUNS372521769
Company NameDevroye Instruments Belgium
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com
Phone+3208807064
Emailinfo@devroyeinstruments.com

Device Dimensions

Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter
Outer Diameter1 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105430003362198 [Primary]

FDA Product Code

GEYMotor, Surgical Instrument, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

[05430003362198]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-19
Device Publish Date2025-05-09

Devices Manufactured by Devroye Instruments Belgium

05430003362006 - WAW WIRELESS HANDPIECE2025-05-19 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 HANDPIECE2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
05430003362020 - WAW PEDAL2025-05-19 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 STATION2025-05-19 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 System2025-05-19 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 BOX2025-05-19 The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hai
05430003362068 - WAW SOFTWARE2025-05-19 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 1.002025-05-19 The WAW Hybrid Tornado Punch is a single use medical device intended to prepare follicular units for extraction from a patient's
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