DEVICE: WAW HYBRID TORNADO PUNCH 0.95 (05430003362143)

Device Identifier (DI) Information

WAW HYBRID TORNADO PUNCH 0.95
0.952508
In Commercial Distribution

Devroye Instruments Belgium
05430003362143
GS1

1
372521769 *Terms of Use
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).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35290 Hair extraction punch
A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEY Motor, Surgical Instrument, Ac-Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 0.95 Millimeter
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Device Record Status

af4b8255-a5f3-4a26-ba44-01e602679513
May 19, 2025
1
May 09, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+3208807064
info@devroyeinstruments.com
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