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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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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
No Description
Glustich Inc
GLTWI05C
Not in Commercial Distribution

  • D795G000151 ()
  • D795G000150 ()
  • D795G000152 ()


  • Skin-approximation adhesive
GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive. GluStitch Twist Tissue Adhesive is intended for the topical closure of surgical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch Twist may be used in conjunction with, but not in place of, deep dermal stitches.
Glustich Inc
GLTWI05
In Commercial Distribution

  • D795112 ()
  • D795110 ()
  • D795111 ()
GLTWI05

  • Skin-approximation adhesive
No Description
Glustich Inc
GLTWI05
Not in Commercial Distribution

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


  • Skin-approximation adhesive
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
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 Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1171
In Commercial Distribution

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


  • Silicone dental impression material
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
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