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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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 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
UV1014
In Commercial Distribution

  • 09348992000686 ()

  • Length: 14 Centimeter
  • Width: 1 Centimeter
V1014

  • 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
UC0614C
In Commercial Distribution

  • 09348992000631 ()

  • Length: 6 Centimeter
  • Width: 14 Centimeter
C0614C

  • 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
UC0508
In Commercial Distribution

  • 09348992000617 ()

  • 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

  • 09348992000594 ()

  • Length: 4 Centimeter
  • Width: 4 Centimeter
C0404

  • 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
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, 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
UV2080
In Commercial Distribution

  • 09348992000532 ()

  • Length: 2 Centimeter
  • Width: 8 Centimeter
V2080

  • Cardiovascular patch, animal-derived
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, 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
UV0880
In Commercial Distribution

  • 09348992000525 ()

  • Length: 0.8 Centimeter
  • Width: 8 Centimeter
V0880

  • 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
UC0614C
In Commercial Distribution

  • 09348992000495 ()

  • Length: 6 Centimeter
  • Width: 14 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
UC0610C
In Commercial Distribution

  • 09348992000488 ()

  • Length: 6 Centimeter
  • Width: 10 Centimeter
C0610

  • 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
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
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
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
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
UV1014
In Commercial Distribution

  • 09348992000303 ()

  • Width: 1 Centimeter
  • Length: 14 Centimeter
V1014

  • Cardiovascular patch, animal-derived
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
UV2080
In Commercial Distribution

  • 09348992000273 ()

  • Width: 8 Centimeter
  • Length: 2 Centimeter
V2080

  • Cardiovascular patch, animal-derived
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
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
UC0610C
In Commercial Distribution

  • 09348992000228 ()

  • Width: 10 Centimeter
  • Length: 6 Centimeter
C0610

  • 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
UC0404A
In Commercial Distribution

  • 09348992000181 ()

  • 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
UC0202
In Commercial Distribution

  • 09348992000105 ()

  • Width: 2 Centimeter
  • Length: 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, 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
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
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
111-42-1602
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
111-42-1302
In Commercial Distribution

  • 09348215054618 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0801
In Commercial Distribution

  • 09348215053345 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-001
In Commercial Distribution

  • 09348215039882 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-022
In Commercial Distribution

  • 09348215039813 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-021
In Commercial Distribution

  • 09348215039806 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-020
In Commercial Distribution

  • 09348215039790 ()


  • Surgical implant template, reusable
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
111-42-1402
In Commercial Distribution

  • 09348215054625 ()


  • 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
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