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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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ENDOTRACHEAL TUBE, CUFFED, SIZE: 8.0MM
CUSTOMED INC
712057143013
In Commercial Distribution

  • M20890030130 ()
  • M20890030131 ()
  • M20890030132 ()

  • Lumen/Inner Diameter: 8.0 Millimeter
9003013

  • Basic endotracheal tube, single-use
ENDOTRACHEAL TUBE, CUFFED, SIZE: 7.0MM
CUSTOMED INC
712057143011
In Commercial Distribution

  • M20890030110 ()
  • M20890030111 ()
  • M20890030112 ()

  • Lumen/Inner Diameter: 7.0 Millimeter
9003011

  • Basic endotracheal tube, single-use
ENDOTRACHEAL TUBE, CUFFED, SIZE: 6.5MM
CUSTOMED INC
712057143010
In Commercial Distribution

  • M20890030100 ()
  • M20890030101 ()
  • M20890030102 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
9003010

  • Basic endotracheal tube, single-use
ENDOTRACHEAL TUBE, CUFFED, SIZE: 5.5MM
CUSTOMED INC
712057143008
In Commercial Distribution

  • M20890030082 ()
  • M20890030081 ()
  • M20890030080 ()

  • Lumen/Inner Diameter: 5.5 Millimeter
9003008

  • Basic endotracheal tube, single-use
ENDOTRACHEAL TUBE, CUFFED, SIZE: 5.0MM
CUSTOMED INC
712057143007
In Commercial Distribution

  • M20890030072 ()
  • M20890030071 ()
  • M20890030070 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
9003007

  • Basic endotracheal tube, single-use
ENDOTRACHEAL TUBE UNCUFFED, SIZE: 5.5MM
CUSTOMED INC
712057143006
In Commercial Distribution

  • M20890030060 ()
  • M20890030061 ()
  • M20890030062 ()

  • Lumen/Inner Diameter: 5.5 Millimeter
9003006

  • Basic endotracheal tube, single-use
ENDOTRACHEAL TUBE UNCUFFED, SIZE: 4.5MM
CUSTOMED INC
712057143004
In Commercial Distribution

  • M20890030040 ()
  • M20890030041 ()
  • M20890030042 ()

  • Lumen/Inner Diameter: 4.5 Millimeter
9003004

  • Basic endotracheal tube, single-use
Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.
SERIM RESEARCH CORPORATION
5119C
In Commercial Distribution

  • M1745119C2 ()
  • M1745119C ()
  • M1745119C0 ()
  • M1745119IN ()
5119C

  • Haemodialysis system blood leak detector
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
Bite Registration Regular Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1170
In Commercial Distribution

  • D796117010 ()
  • D7961170 ()
  • D79611702 ()
  • D79611703 ()


  • 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
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
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
GLTWI05C
In Commercial Distribution

  • D795122 ()
  • D795120 ()
  • D795121 ()
GLTWI05C

  • 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
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
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