BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PUNCH SUPPORT BOX

    DI: 05430003362228 · Model: 1 · Devroye Instruments Belgium
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PUNCH SUPPORT BOX
    Primary DI
    05430003362228
    Version / Model
    1
    Company Name
    Devroye Instruments Belgium
    Labeler DUNS
    372521769
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-09
    Public Version
    1
    Public Version Date
    2025-05-19
    Public Version Status
    New
    Public Device Record Key
    c51681d1-62c5-4311-8ec7-8a9a50b5f4e7

    Device Description

    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.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEY Motor, Surgical Instrument, Ac-Powered

    GMDN Terms

    Code Name
    44680 Electrosurgical handpiece, reusable

    Identifiers

    Type ID
    Primary 05430003362228

    Customer Contacts

    Phone
    +3208807064
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    50 – 105 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 65 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -5 – 40 Degrees Celsius
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    50 – 105 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 65 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius