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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
MEDITECH SPINE, LLC
S1-7-41141-20
In Commercial Distribution

  • B167S2741141201 ()
  • B167S4741141202 ()
  • B167S1741141200 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-41141-18
In Commercial Distribution

  • B167S4741141182 ()
  • B167S2741141181 ()
  • B167S1741141180 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-41141-16
In Commercial Distribution

  • B167S2741141161 ()
  • B167S4741141162 ()
  • B167S1741141160 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-41141-14
In Commercial Distribution

  • B167S2741141141 ()
  • B167S4741141142 ()
  • B167S1741141140 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-41141-12
In Commercial Distribution

  • B167S4741141122 ()
  • B167S2741141121 ()
  • B167S1741141120 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-41141-10
In Commercial Distribution

  • B167S2741141101 ()
  • B167S4741141102 ()
  • B167S1741141100 ()


  • Spinal bone screw, non-bioabsorbable
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MA1251
Not in Commercial Distribution

  • B353MA12512 ()
  • B353MA12511 ()
  • B353MA12513 ()
MA1251_US

  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1253
In Commercial Distribution

  • B353LP12532 ()
  • B353LP12531 ()
  • B353LP12533 ()
LP1253_US

  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution

  • B353LP11103 ()
  • B353LP11102 ()
  • B353LP11101 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution

  • B353CV12452 ()
  • B353CV12451 ()
  • B353CV12453 ()


  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder
Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder
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
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