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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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No Description
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.
N-2515
In Commercial Distribution

  • G001N25151 ()
  • G001N25150 ()
  • G001N25152 ()


  • Hypodermic needle, single-use
No Description
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.
N-2510
In Commercial Distribution

  • G001N25101 ()
  • G001N25100 ()
  • G001N25102 ()


  • Hypodermic needle, single-use
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
eXact VPS Impression Material Monophase Fast Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1147
In Commercial Distribution

  • D796114714 ()
  • D7961147 ()
  • D79611472 ()
  • D79611473 ()


  • Silicone dental impression material
eXact VPS Impression Material Monophase Regular Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1146
In Commercial Distribution

  • D796114613 ()
  • D7961146 ()
  • D79611462 ()
  • D79611463 ()


  • Silicone dental impression material
eXact VPS Impression Material Heavy Fast Set 50ml. Cartridge - MARK3
CARGUS INTERNATIONAL, INC
1145
In Commercial Distribution

  • D796114512 ()
  • D79611450 ()
  • D796114513 ()
  • D796114514 ()


  • Silicone dental impression material
eXact VPS Impression Material Heavy Regular Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1144
In Commercial Distribution

  • D796114411 ()
  • D7961144 ()
  • D79611442 ()
  • D79611443 ()


  • Silicone dental impression material
eXact VPS Impression Material Medium Fast Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1143
In Commercial Distribution

  • D796114310 ()
  • D7961143 ()
  • D79611432 ()
  • D79611433 ()


  • Silicone dental impression material
eXact VPS Impression Material Medium Regular 50ml. Cartridges Set 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1142
In Commercial Distribution

  • D79611421 ()
  • D7961142 ()
  • D79611422 ()
  • D79611423 ()


  • Silicone dental impression material
eXact VPS Impression Material Light Fast Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1141
In Commercial Distribution

  • D79611411 ()
  • D7961141 ()
  • D79611412 ()
  • D79611413 ()


  • Silicone dental impression material
eXact VPS Impression Material Light Regular Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
11401
In Commercial Distribution

  • D79611401 ()
  • D7961140 ()
  • D79611402 ()
  • D79611403 ()


  • Silicone dental impression material
No Description
Glustich Inc
GLTWI05
Not in Commercial Distribution

  • D7950000131 ()
  • D7950000130 ()
  • D7950000132 ()


  • Skin-approximation adhesive
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
Bite Registration Mint Chocolate Chip Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1176
In Commercial Distribution

  • D796117616 ()
  • D7961176 ()
  • D79611762 ()
  • D79611763 ()


  • Silicone dental impression material
Bite Registration Hard Bite Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1173
In Commercial Distribution

  • D796117313 ()
  • D7961173 ()
  • D79611732 ()
  • D79611733 ()


  • Silicone dental impression material
Bite Registration Super Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1172
In Commercial Distribution

  • D796117212 ()
  • D7961172 ()
  • D79611722 ()
  • D79611723 ()


  • Silicone dental impression material
Bite Registration Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1171
In Commercial Distribution

  • D796117111 ()
  • D79611710 ()
  • D79611712 ()
  • D79611713 ()


  • Silicone dental impression material
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