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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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Electroconvulsive Therapy Instrument
SOMATICS, LLC
System IV
In Commercial Distribution

  • 00850298007003 ()

  • Weight: 22 Pound
  • Depth: 5.25 Inch
  • Height: 13 Inch
  • Width: 18 Inch
EDIV

  • Electroporation therapy system generator
Digital Transmitter for the Avery Breathing Pacemaker System
Avery Biomedical Devices Inc
NeurostimulatorTransmitter Digital
In Commercial Distribution

  • 00850252006066 ()
Spirit

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
RECELL GO mini Autologous Cell Harvesting Device (Preparation Kit)
AVITA MEDICAL AMERICAS, LLC
AVRL0105
In Commercial Distribution

  • 00851707004361 ()


  • Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 480
In Commercial Distribution

  • 00851707004262 ()
AVRL0102

  • Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution

  • 00851707004200 ()
AVRL0101

  • Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution

  • 00851707004149 ()
C3RL01-B:US

  • Autologous skin cell grafting kit
The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-NV-6-40
In Commercial Distribution

  • 00851616007651 ()
NG-NV-6-40

  • Peripheral angioplasty balloon catheter, basic
  • Carotid artery embolic protection system
  • Bare-metal carotid artery stent
The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-NV-6-30
In Commercial Distribution

  • 00851616007644 ()
NG-NV-6-30

  • Peripheral angioplasty balloon catheter, basic
  • Carotid artery embolic protection system
  • Bare-metal carotid artery stent
The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-NV-7-30
In Commercial Distribution

  • 00851616007637 ()
NG-NV-7-30

  • Peripheral angioplasty balloon catheter, basic
  • Bare-metal carotid artery stent
  • Carotid artery embolic protection system
The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-NV-7-40
In Commercial Distribution

  • 00851616007620 ()
NG-NV-7-40

  • Peripheral angioplasty balloon catheter, basic
  • Carotid artery embolic protection system
  • Bare-metal carotid artery stent
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