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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
1
In Commercial Distribution

  • 05430003362051 ()


  • Electrosurgical handpiece, reusable
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-997
Not in Commercial Distribution

  • 04953170077760 ()


  • Gastrointestinal catheter/endoscope tracking system
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-998
Not in Commercial Distribution

  • 04953170077753 ()


  • Gastrointestinal catheter/endoscope tracking system
No Description
TOPCON CORPORATION
EF-2
In Commercial Distribution

  • 04562123289923 ()


  • Ophthalmic fundus camera
No Description
Biomet Orthopedics, LLC
01800
In Commercial Distribution

  • 00880304504738 ()
01800

  • External orthopaedic fixation system, single-use
Truss Wire x 1.8mm
Metalogix
900217
In Commercial Distribution

  • 00854641008419 ()

  • Length: 16.93 Inch
  • Diameter: 1.8mm


  • External orthopaedic fixation system, single-use
Smooth Wire x 1.8mm
Metalogix
900117
In Commercial Distribution

  • 00854641008402 ()

  • Length: 16.93 Inch
  • Diameter: 1.8mm


  • External orthopaedic fixation system, single-use
Steinmann Pin x 6mm
Metalogix
624006
In Commercial Distribution

  • 00854641008396 ()

  • Diameter: 6mm


  • External orthopaedic fixation system, single-use
Steinmann Pin x 5mm
Metalogix
624005
In Commercial Distribution

  • 00854641008389 ()

  • Diameter: 5mm


  • External orthopaedic fixation system, single-use
Steinmann Pin x 4mm
Metalogix
624004
In Commercial Distribution

  • 00854641008372 ()

  • Diameter: 4mm


  • External orthopaedic fixation system, single-use
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