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

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


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

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

  • Bioelectrical body composition analyser
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 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 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
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
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
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
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
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 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
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
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
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
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
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 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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