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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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J5 Myo-Monitor - D79244500

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

Myotrode SG Solid Gel TENS Electrodes - D79243001

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

Plasdent DuralProof Earloop Mask - D832MK26

DuralProof(TM) Earloop Face Mask - Pink (50pcs/box)
PLASDENT CORPORATION
MK2
In Commercial Distribution

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

  • Surgical/medical respirator, antimicrobial

Premium Plus - D838S901XLIB2

MICRO APPLICATORS
Premium Plus International Limited
S901XL-IB
In Commercial Distribution

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


  • Dental material application tool, single-use

Premium Plus - D838S901XLA2

MICRO APPLICATORS
Premium Plus International Limited
S901XL-A
In Commercial Distribution

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


  • Dental material application tool, single-use

Premium Plus - D838S901IY2

MICRO APPLICATORS
Premium Plus International Limited
S901-IY
In Commercial Distribution

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


  • Dental material application tool, single-use

Premium Plus - D838S901IL2

MICRO APPLICATORS
Premium Plus International Limited
S901-IL
In Commercial Distribution

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


  • Dental material application tool, single-use

Premium Plus - D838S901IG2

MICRO APPLICATORS
Premium Plus International Limited
S901-IG
In Commercial Distribution

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


  • Dental material application tool, single-use

Premium Plus - D838S901IB2

MICRO APPLICATORS
Premium Plus International Limited
S901-IB
In Commercial Distribution

  • D838S901IB8 ()
  • D838S901IB6 ()
  • D838S901IB2 ()
  • D838S901IB0 ()


  • Dental material application tool, single-use

Premium Plus - D838S901A2

MICRO APPLICATORS
Premium Plus International Limited
S901A
In Commercial Distribution

  • D838S901A8 ()
  • D838S901A6 ()
  • D838S901A2 ()
  • D838S901A0 ()


  • Dental material application tool, single-use
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