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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 - 09348992000365

CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture
ADMEDUS REGEN PTY LTD
UC0404
In Commercial Distribution

  • 09348992000365 ()

  • Length: 4 Centimeter
  • Width: 4 Centimeter
C0404

  • Cardiovascular patch, animal-derived

VascuCel 3D - 09348992000341

VascuCel™ is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a jar impermeable to air and moisture.
ADMEDUS REGEN PTY LTD
UV1206T
In Commercial Distribution

  • 09348992000341 ()

  • Width: 12 Millimeter
  • Length: 06 Centimeter
V1206T

  • Cardiovascular patch, animal-derived

VascuCel - 09348992000303

No Description
ADMEDUS REGEN PTY LTD
UV1014
In Commercial Distribution

  • 09348992000303 ()

  • Width: 1 Centimeter
  • Length: 14 Centimeter
V1014

  • Cardiovascular patch, animal-derived

VascuCel - 09348992000266

The VascuCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UV0880
In Commercial Distribution

  • 09348992000266 ()

  • Width: 8 Centimeter
  • Length: 0.8 Centimeter
V0880

  • Cardiovascular patch, animal-derived

CardioCel Neo - 09348992000143

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet acellular collagen.
ADMEDUS REGEN PTY LTD
UC0404N
In Commercial Distribution

  • 09348992000143 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter
C0404

  • Cardiovascular patch, animal-derived

CardioCel - 09348992000082

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 colored, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0208
In Commercial Distribution

  • 09348992000082 ()

  • Width: 8 Centimeter
  • Length: 2 Centimeter
C0208

  • Cardiovascular patch, animal-derived

CardioCel - 09348992000037

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
UC0614
In Commercial Distribution

  • 09348992000037 ()

  • Width: 14 Centimeter
  • Length: 6 Centimeter
C0614

  • Cardiovascular patch, animal-derived

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

NA - 03664539000091

SEEG DEPTH ELECTRODE, 15 CONTACTS, EXPLORATION LENGTH 51MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000091 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15AM

  • Depth electrode

NA - 03664539000084

SEEG DEPTH ELECTRODE, 12 CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000084 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-12AT

  • Depth electrode

NA - 03664539000060

SEEG DEPTH ELECTRODE, 10 CONTACTS, EXPLORATION LENGTH 33.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000060 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-10AT

  • Depth electrode

NA - 03664539000039

SEEG DEPTH ELECTRODE, 8 CONTACTS, EXPLORATION LENGTH 26.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000039 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-08AM

  • Depth electrode

NA - 03664539000015

SEEG DEPTH ELECTRODE, 5 CONTACTS, EXPLORATION LENGTH 16MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000015 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-05AM

  • Depth electrode

NA - 03664539003894

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 50, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003894 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B51P12

  • Depth electrode

NA - 03664539003887

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 42, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003887 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B40P12

  • Depth electrode

NA - 03664539003870

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 34, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003870 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B33P12

  • Depth electrode

NA - 03664539003689

"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003733 ()
  • 03664539003689 ()

  • Length 40 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-140SMS-10

  • Depth electrode

NA - 03664539003672

"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 5MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003726 ()
  • 03664539003672 ()

  • Length 40 Millimeters Length of the self-tapping thread 5 Millimeters
ACS-040SMS-10

  • Depth electrode

NA - 03664539003665

"SET OF 10 ANCHOR BOLTS, LENGTH 35MM,LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003719 ()
  • 03664539003665 ()

  • Length 35 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-135SMS-10

  • Depth electrode

NA - 03664539003658

"SET OF 10 ANCHOR BOLTS, LENGTH 30MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003702 ()
  • 03664539003658 ()

  • Length 30 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-130SMS-10

  • Depth electrode

NA - 03664539003641

SET OF 10 ANCHOR BOLTS, LENGTH 25MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003696 ()
  • 03664539003641 ()

  • Length 25 Millimeters Length of the self-tapping part 10 Millimeters
ACS-125SMS-10

  • Depth electrode

NA - 03664539003535

TWIST DRILL FOR ANCHOR BOLT, LENGTH 250MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
In Commercial Distribution

  • 03664539003535 ()
KIP-ACS-515B

  • Depth electrode

NA - 03664539003467

SEEG DEPTH ELECTRODE, 9 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 40,8, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003467 ()

  • " Macro Contact Length 2 Millimeters Macro Contact Spacing 4,1 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-09A51D08

  • Depth electrode

NA - 03664539003450

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS, EXPLORATION LENGTH 50, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003450 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-06B51D12

  • Depth electrode
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