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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 - D796114310

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

MARK3 - D79611421

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

MARK3 - D79611411

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

MARK3 - D79611401

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

GLUSTITCH TWIST - D7950000130

No Description
Glustich Inc
GLTWI05
Not in Commercial Distribution

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


  • Skin-approximation adhesive

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

MARK3 - D796117616

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

MARK3 - D796117313

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

MARK3 - D796117212

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

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


  • Silicone dental impression material

MARK3 - D796117111

Bite Registration Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1171
In Commercial Distribution

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


  • Silicone dental impression material

MARK3 - D796117010

Bite Registration Regular Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1170
In Commercial Distribution

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


  • Silicone dental impression material

GLUSTITCH TWIST - D795G000150

No Description
Glustich Inc
GLTWI05C
Not in Commercial Distribution

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


  • Skin-approximation adhesive

GluStitch® Twist - D795120

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 - D795110

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

U400 ImpSoft Software - B277292U400CD0

Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser

Body Composition Analysis Software - B277292DF50CD0

DF50 Body Composition Analysis Software
IMPEDIMED LIMITED
4.1.2
Not in Commercial Distribution

  • B277292DF50CD1 ()
  • B277292DF50CD0 ()
  • B277292DF50CD2 ()
292-DF50CD

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27727270000

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor.
IMPEDIMED LIMITED
2727000
In Commercial Distribution

  • B27727270000 ()
  • B27727270001 ()
  • B27727270002 ()
2727000

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27727269950

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor.
IMPEDIMED LIMITED
2727000
In Commercial Distribution

  • B27727269950 ()
  • B27727269951 ()
  • B27727269952 ()
2727000

  • Bioelectrical body composition analyser

Imp SFB7 - B277259SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. ROW Demo-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277259SFB72 ()
  • B277259SFB71 ()
  • B277259SFB70 ()
259-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277259DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. ROW Demo Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277259DF502 ()
  • B277259DF500 ()
  • B277259DF501 ()
229-DF50

  • Bioelectrical body composition analyser

Imp SFB7 - B277253SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. US Demo-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277253SBF72 ()
  • B277253SBF71 ()
  • B277253SFB70 ()
253-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277253DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. US Demo Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277253DF502 ()
  • B277253DF501 ()
  • B277253DF500 ()
229-DF50

  • Bioelectrical body composition analyser

L-Dex® U400 - B277252LDEXU4000

BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. Demo Device
IMPEDIMED LIMITED
U400
In Commercial Distribution

  • B227252LDEXU4002 ()
  • B277252LDEXU4001 ()
  • B277252LDEXU4000 ()
242-LDEXU400

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27725269950

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. Demo Device
IMPEDIMED LIMITED
2526995
In Commercial Distribution

  • B27725269950 ()
  • B27725269951 ()
  • B27725269952 ()
252-SOZO

  • Bioelectrical body composition analyser

Imp SFB7 - B277249SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. ROW Refurbished-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277249SFB70 ()
  • B277249SFB71 ()
  • B277249SFB72 ()


  • Bioelectrical body composition analyser

Imp DF50 - B277249DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. ROW Refurbished Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277249DF502 ()
  • B277249DF501 ()
  • B277249DF500 ()
229-DF50

  • Bioelectrical body composition analyser

Imp SFB7 - B277243SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. US Refurbished- Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277243SFB72 ()
  • B277243SBF71 ()
  • B277243SFB70 ()
243-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277243DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. US Refurbished Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277243DF502 ()
  • B277243DF501 ()
  • B277243DF500 ()
229-DF50

  • Bioelectrical body composition analyser

L-Dex® U400 - B277242LDEXU4000

BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. Refurbished Device
IMPEDIMED LIMITED
U400
In Commercial Distribution

  • B277242LDEXU4002 ()
  • B277242LDEXU4001 ()
  • B277242LDEXU4000 ()
242-LDEXU400

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27724269950

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. Refurbished Device
IMPEDIMED LIMITED
2426995
In Commercial Distribution

  • B27724269952 ()
  • B27724269951 ()
  • B27724269950 ()
242-SOZO

  • Bioelectrical body composition analyser
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