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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CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-05NS-0812
In Commercial Distribution

  • 00850023375049 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0812

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 10 x 15 cm
Helios Cardio Inc.
CMUS-10NS-1015
In Commercial Distribution

  • 00850023375032 ()

  • Length: 10 Centimeter
  • Width: 15 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-1015

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-10NS-0506
In Commercial Distribution

  • 00850023375025 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0506

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm
Helios Cardio Inc.
CMUS-10NS-0816
In Commercial Distribution

  • 00850023375018 ()

  • Length: 8 Centimeter
  • Width: 16 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0816

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0612
In Commercial Distribution

  • 00850023375001 ()

  • Length: 6 Centimeter
  • Width: 12 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0612

  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
AZIYO BIOLOGICS, INC.
CMCV-009-XXL
In Commercial Distribution

  • 10859389005116 ()
  • 00859389005119 ()

  • SubQ


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
AZIYO BIOLOGICS, INC.
CMCV-009-XLG
In Commercial Distribution

  • 10859389005079 ()
  • 00859389005072 ()

  • Extra Large


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
AZIYO BIOLOGICS, INC.
CMCV-009-LRG
In Commercial Distribution

  • 10859389005062 ()
  • 00859389005065 ()

  • Large


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
AZIYO BIOLOGICS, INC.
CMCV-009-MED
In Commercial Distribution

  • 10859389005031 ()
  • 00859389005034 ()

  • Medium


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
AZIYO BIOLOGICS, INC.
CMCV-009-SML
In Commercial Distribution

  • 10859389005024 ()
  • 00859389005027 ()

  • Small


  • Cardiovascular patch, animal-derived
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