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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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Oropharyngeal Airway, Size 110 mm, Non-Sterile
ENDURE INDUSTRIES
OA1121217
In Commercial Distribution

  • B531OA1122 ()
  • B531OA1121 ()
  • B531OA1120 ()

  • Length: 110 Millimeter
OA112

  • Oropharyngeal airway, single-use
Oropharyngeal Airway, Size 100 mm, Non-Sterile
ENDURE INDUSTRIES
OA1021217
In Commercial Distribution

  • B531OA1022 ()
  • B531OA1021 ()
  • B531OA1020 ()

  • Length: 100 Millimeter
OA102

  • Oropharyngeal airway, single-use
MARK3 FluoroGuard 5% NAF VARNISH MINT
CARGUS INTERNATIONAL, INC
1654
In Commercial Distribution

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

  • Dental cavity varnish
MARK3 FluoroGuard 5% NAF VARNISH CARAMEL
CARGUS INTERNATIONAL, INC
1652
In Commercial Distribution

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

  • Dental cavity varnish
MARK3 FluoroGuard 5% NAF VARNISH BUBBLEGUM
CARGUS INTERNATIONAL, INC
1650
In Commercial Distribution

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

  • Dental cavity varnish
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
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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