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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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Type II 30mm
Well Lead Medical Co.,Ltd
F03A023010
In Commercial Distribution

  • 16936881133456 ()
  • 06936881133459 ()
  • 26936881133453 ()


  • Penis wearable urinal
Type II 28mm
Well Lead Medical Co.,Ltd
F03A022810
In Commercial Distribution

  • 16936881133432 ()
  • 06936881133435 ()
  • 26936881133439 ()


  • Penis wearable urinal
Type I 30mm
Well Lead Medical Co.,Ltd
F03A013010
In Commercial Distribution

  • 16936881133395 ()
  • 06936881133398 ()
  • 26936881133392 ()


  • Penis wearable urinal
Type I 28mm
Well Lead Medical Co.,Ltd
F03A012810
In Commercial Distribution

  • 16936881133388 ()
  • 06936881133381 ()
  • 26936881133385 ()


  • Penis wearable urinal
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
Biomet Orthopedics, LLC
8299-10-500
In Commercial Distribution

  • 00887868050268 ()
829910500

  • Instrument tray, reusable
Orthex, Drill 4.8x285mm Solid
ORTHOPEDIATRICS CORP.
Z402-285-48
In Commercial Distribution

  • 00840194428170 ()
Z402-285-48

  • Fluted surgical drill bit, single-use
Type III 41mm
Well Lead Medical Co.,Ltd
F03A034110
In Commercial Distribution

  • 16944932730752 ()
  • 06944932730755 ()
  • 26944932730759 ()


  • Penis wearable urinal
Type III 29mm
Well Lead Medical Co.,Ltd
F03A032910
In Commercial Distribution

  • 16944932730721 ()
  • 06944932730724 ()
  • 26944932730728 ()


  • Penis wearable urinal
Type II 41mm
Well Lead Medical Co.,Ltd
F03A024110
In Commercial Distribution

  • 16944932725574 ()
  • 06944932725577 ()
  • 26944932725571 ()


  • Penis wearable urinal
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