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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AlboSure Vascular Patch 2x9 cm
Lemaitre Vascular, Inc.
AP20090R
In Commercial Distribution

  • 00840663105021 ()
AP20090R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 10 cm
Lemaitre Vascular, Inc.
AP10100R
In Commercial Distribution

  • 00840663104802 ()
AP10100R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 7.5 cm
Lemaitre Vascular, Inc.
AP10075T
In Commercial Distribution

  • 00840663104765 ()
AP10075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 0.8x 7.5 cm
Lemaitre Vascular, Inc.
AP08075T
In Commercial Distribution

  • 00840663104604 ()
AP08075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 0.6x 7.5 cm
Lemaitre Vascular, Inc.
AP06075T
In Commercial Distribution

  • 00840663104543 ()
AP06075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 15 cm
Lemaitre Vascular, Inc.
AP10150R
In Commercial Distribution

  • 00840663104895 ()
AP10150R

  • Cardiovascular patch, animal-derived
16mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD8
In Commercial Distribution

  • 1199028 ()
  • M364119902FD80 ()

  • Outer Diameter: 16 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
16mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD7
In Commercial Distribution

  • M364119902FD70 ()


  • Metallic spinal interbody fusion cage
14mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD6
In Commercial Distribution

  • 1199026 ()
  • M364119902FD60 ()

  • Outer Diameter: 14 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
12mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD4
In Commercial Distribution

  • 1199024 ()
  • M364119902FD40 ()

  • Outer Diameter: 12 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
12mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD3
In Commercial Distribution

  • 1199023 ()
  • M364119902FD30 ()

  • Outer Diameter: 12 Millimeter
  • Length: 21 Millimeter


  • Metallic spinal interbody fusion cage
18mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD10
In Commercial Distribution

  • 11990210 ()
  • M364119902FD100 ()

  • Outer Diameter: 18 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
10mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD1
In Commercial Distribution

  • M364119902FD10 ()
  • 1199021 ()

  • Length: 21 Millimeter
  • Outer Diameter: 10 Millimeter


  • Metallic spinal interbody fusion cage
18mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD9
In Commercial Distribution

  • 1199029 ()
  • M364119902FD90 ()

  • Outer Diameter: 18 Millimeter
  • Length: 21 Millimeter


  • Metallic spinal interbody fusion cage
14mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD5
In Commercial Distribution

  • 1199025 ()
  • M364119902FD50 ()

  • Outer Diameter: 14 Millimeter
  • Length: 21 Millimeter


  • Metallic spinal interbody fusion cage
10mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation
MEDICAL DESIGNS LLC
11-9902-FD2
In Commercial Distribution

  • 1199022 ()
  • M364119902FD20 ()

  • Outer Diameter: 10 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
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
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
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
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
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
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
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-05NS-0506
In Commercial Distribution

  • 00850023375087 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0506

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 7 x 15 cm
Helios Cardio Inc.
CMUS-10NS-0715
In Commercial Distribution

  • 00850023375070 ()

  • Width: 15 Centimeter
  • Height: 1.0 Millimeter
  • Length: 7 Centimeter
CMUS-10NS-0715

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0812
In Commercial Distribution

  • 00850023375063 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 1.0 Millimeter
CMUS-10NS-0812

  • Cardiovascular patch, animal-derived
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 4 x 7 cm
Helios Cardio Inc.
CMUS-05NS-0407
In Commercial Distribution

  • 00850023375056 ()

  • Length: 4 Centimeter
  • Width: 7 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0407

  • Cardiovascular patch, animal-derived
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