Company Name Brand Name GMDN Term 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® 3D 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
UC0405A30
In Commercial Distribution

  • 09348992000655 ()

  • Width: 4 Centimeter
  • Length: 5 Centimeter
  • Angle: 30 degree
C0405A30

  • Cardiovascular patch, animal-derived
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
UC0406A
In Commercial Distribution

  • 09348992000648 ()

  • Width: 4 Centimeter
  • Length: 6 Centimeter
  • Angle: 60 degree
C0406A

  • Cardiovascular patch, animal-derived
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
UC0406A
In Commercial Distribution

  • 09348992000549 ()

  • Angle: 60 degree
  • Length: 6 Centimeter
  • Width: 4 Centimeter
C0406A

  • Cardiovascular patch, animal-derived
CardioCel® 3D 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
UC0406A60
In Commercial Distribution

  • 09348992000358 ()

  • Width: 4 Centimeter
  • Length: 6 Centimeter
  • Angle: 60 degree
C0406A60

  • Cardiovascular patch, animal-derived
CardioCel® 3D 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
UC0405A30
In Commercial Distribution

  • 09348992000334 ()

  • Width: 4 Centimeter
  • Length: 5 Centimeter
  • Angle: 30 degree
C0405A30

  • Cardiovascular patch, animal-derived
CardioCel® 3D 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
UC0307A90
In Commercial Distribution

  • 09348992000327 ()

  • Width: 3 Centimeter
  • Length: 7 Centimeter
  • Angle: 90 degree
C0307A90

  • Cardiovascular patch, animal-derived
No Description
ADMEDUS REGEN PTY LTD
UC0406A
In Commercial Distribution

  • 09348992000280 ()

  • Width: 4 Centimeter
  • Length: 6 Centimeter
  • Angle: 60 degree
C0406A

  • Cardiovascular patch, animal-derived
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® 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
UC0508
In Commercial Distribution

  • 09348992000372 ()

  • Length: 5 Centimeter
  • Width: 8 Centimeter
C0508

  • Cardiovascular patch, animal-derived
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
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
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
UC0508
In Commercial Distribution

  • 09348992000020 ()

  • Width: 8 Centimeter
  • Length: 5 Centimeter
C0508

  • Cardiovascular patch, animal-derived
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
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
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
Models 400 and 550 Implantable Infusion Pump Refill Kit
CODMAN & SHURTLEFF, INC.
IP-40820
In Commercial Distribution

  • 10886704044109 ()
IP40820

  • Implantable intrathecal infusion pump, nonprogrammable
MODEL 400 REFILL TUBING SET
CODMAN & SHURTLEFF, INC.
IP40812
Not in Commercial Distribution

  • 10886704044093 ()
IP40812

  • Implantable intrathecal infusion pump, nonprogrammable
3000 Series High Temperature Drape for use with CODMAN O.R. Heater AP-09100
CODMAN & SHURTLEFF, INC.
AP-09150
In Commercial Distribution

  • 20886704043826 ()
  • 10886704043829 ()
AP09150

  • Implantable intrathecal infusion pump, nonprogrammable
Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
CODMAN & SHURTLEFF, INC.
AP-03000UL
In Commercial Distribution

  • 10886704043621 ()
AP03000UL

  • Implantable intrathecal infusion pump, nonprogrammable
Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
CODMAN & SHURTLEFF, INC.
AP-03000M
In Commercial Distribution

  • 10886704043614 ()
AP03000M

  • Implantable intrathecal infusion pump, nonprogrammable
Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
CODMAN & SHURTLEFF, INC.
AP-03000L
In Commercial Distribution

  • 10886704043607 ()
AP03000L

  • Implantable intrathecal infusion pump, nonprogrammable
Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
CODMAN & SHURTLEFF, INC.
AP-03000H
In Commercial Distribution

  • 10886704043591 ()
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable
Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
CODMAN & SHURTLEFF, INC.
AP-04009
In Commercial Distribution

  • 20886704072888 ()
  • 10886704072881 ()
AP04009

  • Implantable intrathecal infusion pump, nonprogrammable
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3322-0021
Not in Commercial Distribution

  • 08806395494934 ()
3322-0021

  • Spinal fixation plate, non-bioabsorbable
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3322-0015
Not in Commercial Distribution

  • 08806395494392 ()
3322-0015

  • Spinal fixation plate, non-bioabsorbable
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3300-5125
In Commercial Distribution

  • 08806395497195 ()
3300-5125

  • Spinal fixation plate, non-bioabsorbable
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