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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No Description
Edwards Lifesciences LLC
4700
In Commercial Distribution

  • 00690103144178 ()

  • 10 CENTIMETERS WIDE BY 15 CENTIMETERS LONG. USER WILL TAILOR TO DESIRED SIZE.
4700

  • Cardiovascular patch, animal-derived
EARP, 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP1425-0008
In Commercial Distribution

  • 00810135960007 ()

  • Depth: 14 Millimeter
  • Width: 25 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP2X9
In Commercial Distribution

  • 00690103199048 ()

  • 2 CM X 9 CM
DP2X9

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP1X6
In Commercial Distribution

  • 00690103199031 ()

  • 1 CM X 6 CM
DP1X6

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP08X8
In Commercial Distribution

  • 00690103199024 ()

  • 0.8 CM X 8 CM
DP08X8

  • Cardiovascular patch, animal-derived
No Description
Synapse Biomedical, Inc.
21-0039-99
In Commercial Distribution

  • 00852184003588 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
CORMATRIX CARDIOVASCULAR, INC.
CMCP5P-710
In Commercial Distribution

  • 00850003965017 ()

  • Width: 10 Centimeter
  • Length: 7 Centimeter


  • Cardiovascular patch, animal-derived
CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
CORMATRIX CARDIOVASCULAR, INC.
CMCP5P-055
In Commercial Distribution

  • 00850003965000 ()

  • Length: 5 Centimeter


  • Cardiovascular patch, animal-derived
No Description
Synapse Biomedical, Inc.
22-0004
In Commercial Distribution

  • 00852184003342 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0022
In Commercial Distribution

  • 00852184003403 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0030
In Commercial Distribution

  • 00852184003434 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0029
In Commercial Distribution

  • 00852184003427 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1803
In Commercial Distribution

  • 09348215054755 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1603
In Commercial Distribution

  • 09348215054748 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1503
In Commercial Distribution

  • 09348215054731 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1403
In Commercial Distribution

  • 09348215054724 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1303
In Commercial Distribution

  • 09348215054717 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1203
In Commercial Distribution

  • 09348215054700 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1103
In Commercial Distribution

  • 09348215054694 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1003
In Commercial Distribution

  • 09348215054687 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0903
In Commercial Distribution

  • 09348215054670 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0803
In Commercial Distribution

  • 09348215054663 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1802
In Commercial Distribution

  • 09348215054656 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1602
In Commercial Distribution

  • 09348215054649 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1502
In Commercial Distribution

  • 09348215054632 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1402
In Commercial Distribution

  • 09348215054625 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1302
In Commercial Distribution

  • 09348215054618 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1202
In Commercial Distribution

  • 09348215054601 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1102
In Commercial Distribution

  • 09348215054595 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1002
In Commercial Distribution

  • 09348215054588 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0902
In Commercial Distribution

  • 09348215054571 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0802
In Commercial Distribution

  • 09348215054564 ()


  • Uncoated femoral stem prosthesis, one-piece
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
UC0202
In Commercial Distribution

  • 09348992000402 ()

  • Length: 2 Centimeter
  • Width: 2 Centimeter
C0202

  • 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, off-white, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0202
In Commercial Distribution

  • 09348992000105 ()

  • Width: 2 Centimeter
  • Length: 2 Centimeter
C0202

  • 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
UC0404N
In Commercial Distribution

  • 09348992000600 ()

  • Length: 4 Centimeter
  • Width: 4 Centimeter
C0404N

  • 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
UC0508N
In Commercial Distribution

  • 09348992000624 ()

  • Length: 5 Centimeter
  • Width: 8 Centimeter
C0508N

  • 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
UC0508N
In Commercial Distribution

  • 09348992000457 ()

  • 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
UC0404N
In Commercial Distribution

  • 09348992000440 ()

  • 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, off-white, moist, pre-cut, flat sheet of acellular collagen
ADMEDUS REGEN PTY LTD
UC0508N
In Commercial Distribution

  • 09348992000150 ()

  • 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, 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
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