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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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NOROTRODES are silver-silver chloride electrodes for surface EMG applications. Contact surfaces pre-jelled with hypoallergenic jel that is water soluble for quick cleanup. Mounted on hypoallergenic adhesive. Silver snap connectors.
MYOTRONICS NOROMED, INC
N120
In Commercial Distribution

  • D792N12013 ()
  • D792N12011 ()
  • D792N12012 ()


  • Analytical non-scalp cutaneous electrode
Duotrodes are silver-silver chloride, bi-polar electrodes for surface EMG applications.
MYOTRONICS NOROMED, INC
6145
In Commercial Distribution

  • D79261453 ()
  • D79261451 ()
  • D79261452 ()


  • Analytical non-scalp cutaneous electrode
The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication.
MYOTRONICS NOROMED, INC
J5
In Commercial Distribution

  • D79244500 ()
  • D7924450C0 ()
  • D7924450J0 ()
4450

  • Analgesic transcutaneous electrical nerve stimulation system
36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for use with the Myomonitor and BNS-40 unit.
MYOTRONICS NOROMED, INC
4300
In Commercial Distribution

  • D79243003 ()
  • D79243001 ()
  • D79243002 ()


  • Transcutaneous electrical stimulation electrode, single-use
DuralProof(TM) Earloop Face Mask - Pink (50pcs/box)
PLASDENT CORPORATION
MK2
In Commercial Distribution

  • D832MK265 ()
  • D832MK26 ()
  • D832MK261 ()
MK2-6

  • Surgical/medical respirator, antimicrobial
MICRO APPLICATORS
Premium Plus International Limited
S901XL-IB
In Commercial Distribution

  • D838S901XLIB8 ()
  • D838S901XLIB6 ()
  • D838S901XLIB2 ()
  • D838S901XLIB0 ()


  • Dental material application tool, single-use
MICRO APPLICATORS
Premium Plus International Limited
S901XL-A
In Commercial Distribution

  • D838S901XLA8 ()
  • D838S901XLA6 ()
  • D838S901XLA2 ()
  • D838S901XLA0 ()


  • Dental material application tool, single-use
MICRO APPLICATORS
Premium Plus International Limited
S901-IY
In Commercial Distribution

  • D838S901IY8 ()
  • D838S901IY6 ()
  • D838S901IY2 ()
  • D838S901IY0 ()


  • Dental material application tool, single-use
MICRO APPLICATORS
Premium Plus International Limited
S901-IL
In Commercial Distribution

  • D838S901IL8 ()
  • D838S901IL6 ()
  • D838S901IL2 ()
  • D838S901IL0 ()


  • Dental material application tool, single-use
MICRO APPLICATORS
Premium Plus International Limited
S901-IG
In Commercial Distribution

  • D838S901IG8 ()
  • D838S901IG6 ()
  • D838S901IG2 ()
  • D838S901IG0 ()


  • Dental material application tool, single-use
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