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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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EnVisio - 00851674008041

Envisio Navigator and Calibration Disk
Elucent Medical, Inc.
NAV-PENCIL
Not in Commercial Distribution

  • 00851674008041 ()
NAV-PENCIL

  • Radiological image marker, implantable

EnVisio - 00851674008034

EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display
Elucent Medical, Inc.
ENVISIO-SYS
In Commercial Distribution

  • 00851674008034 ()
ENVISIO-SYS

  • Radiological image marker, implantable

Neuroguard IEP® System - 00851616007651

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

Neuroguard IEP® System - 00851616007644

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

Neuroguard IEP® System - 00851616007637

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

Neuroguard IEP® System - 00851616007620

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

Neuroguard IEP® System - 00851616007613

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-0740-140-2
In Commercial Distribution

  • 00851616007613 ()
NG-0740-140-2

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

Neuroguard IEP® System - 00851616007606

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-0730-140-2
In Commercial Distribution

  • 00851616007606 ()
NG-0730-140-2

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

Neuroguard IEP® System - 00851616007590

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-0640-140-2
In Commercial Distribution

  • 00851616007590 ()
NG-0640-140-2

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

Neuroguard IEP® System - 00851616007583

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-0630-140-2
In Commercial Distribution

  • 00851616007583 ()
NG-0630-140-2

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