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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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CardioCel - 09348992000013

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, light yellow to beige coloured, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0404
In Commercial Distribution

  • 09348992000013 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter
C0404

  • Cardiovascular patch, animal-derived

CardioCel - 09348992000006

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, light yellow to beige coloured, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0202
In Commercial Distribution

  • 09348992000006 ()

  • Width: 2 Centimeter
  • Length: 2 Centimeter
C0202

  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160555

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440579
In Commercial Distribution

  • 04035479160647 ()
  • 04035479160555 ()

  • SubQ


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160548

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440578
In Commercial Distribution

  • 04035479160548 ()
  • 04035479160654 ()

  • Width: 9.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160531

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440577
In Commercial Distribution

  • 04035479160531 ()
  • 04035479160616 ()

  • Width: 8.0 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160524

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440576
In Commercial Distribution

  • 04035479160524 ()
  • 04035479160623 ()

  • Width: 6.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160517

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440575
In Commercial Distribution

  • 04035479160517 ()
  • 04035479160630 ()


  • Cardiovascular patch, animal-derived

VasCure for Vascular Repair - 00859389005140

VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
AZIYO BIOLOGICS, INC.
CMCV-013-609
In Commercial Distribution

  • 10859389005147 ()
  • 00859389005140 ()

  • Height: 1 Centimeter
  • Width: 10 Centimeter


  • Cardiovascular patch, animal-derived

VasCure for Vascular Repair - 00859389005126

VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
AZIYO BIOLOGICS, INC.
CMCV-011-606
In Commercial Distribution

  • 10859389005123 ()
  • 00859389005126 ()

  • Height: 2 Centimeter
  • Width: 10 Centimeter


  • Cardiovascular patch, animal-derived

CanGaroo Envelope - 00859389005119

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
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