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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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MARK3 - D7961654

MARK3 FluoroGuard 5% NAF VARNISH MINT
CARGUS INTERNATIONAL, INC
1654
In Commercial Distribution

  • D79616541 ()
  • D7961654 ()
  • D79616542 ()
1654

  • Dental cavity varnish

MARK3 - D7961652

MARK3 FluoroGuard 5% NAF VARNISH CARAMEL
CARGUS INTERNATIONAL, INC
1652
In Commercial Distribution

  • D79616521 ()
  • D7961652 ()
  • D79616522 ()
1652

  • Dental cavity varnish

MARK3 - D7961650

MARK3 FluoroGuard 5% NAF VARNISH BUBBLEGUM
CARGUS INTERNATIONAL, INC
1650
In Commercial Distribution

  • D79616501 ()
  • D7961650 ()
  • D79616502 ()
1650

  • Dental cavity varnish

Endure - B531ES1450

Endotracheal Stylet, Size= 14 Fr, fits endotracheal tubes of sizes internal diameter > 5.5mm.
ENDURE INDUSTRIES
ES1451217
In Commercial Distribution

  • B531ES1452 ()
  • B531ES1451 ()
  • B531ES1450 ()

  • Size- 14 Fr
ES145

  • Artificial airway stylet, single-use

Endure - B531ES1050

Endotracheal Stylet, size= 10Fr, fits endotracheal tubes of sizes internal diameter 4-5 mm.
ENDURE INDUSTRIES
ES1051217
In Commercial Distribution

  • B531ES1052 ()
  • B531ES1051 ()
  • B531ES1050 ()

  • size- 10Fr
ES105

  • Artificial airway stylet, single-use

Norotrode 20 - D792N12011

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

Myotronics 6145 Duotrodes - D79261451

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

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

MARK3 - D79611771

MAX BITE Bite Registration Mint Chocolate Chip Super Fast - MARK3®*
CARGUS INTERNATIONAL, INC
1177
In Commercial Distribution

  • D79611772 ()
  • D79611771 ()
  • D79611773 ()
  • D796117717 ()
1177

  • Silicone dental impression material
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