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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VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG02515
In Commercial Distribution

  • 00085412818634 ()
VG02515

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0209
In Commercial Distribution

  • 00085412818573 ()
VG0209

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG01510
In Commercial Distribution

  • 00085412818559 ()
VG01510

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0114
In Commercial Distribution

  • 00085412818535 ()
VG0114

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0110
In Commercial Distribution

  • 00085412818511 ()
VG0110

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0108
In Commercial Distribution

  • 00085412818498 ()
VG0108

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0106
In Commercial Distribution

  • 00085412818474 ()
VG0106

  • 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
UV1014
In Commercial Distribution

  • 09348992000563 ()

  • Length: 14 Centimeter
  • Width: 1 Centimeter
V1014

  • 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
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
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
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

  • 09348992000693 ()

  • Width: 2 Centimeter
  • Length: 8 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
UV1014
In Commercial Distribution

  • 09348992000686 ()

  • Length: 14 Centimeter
  • Width: 1 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
UV0880
In Commercial Distribution

  • 09348992000679 ()

  • Length: 0.8 Centimeter
  • Width: 8 Centimeter
V0880

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 2.5cm x 15cm, eIFU
Lemaitre Vascular, Inc.
e2.5P15
In Commercial Distribution

  • 00840663108831 ()
e2.5P15

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 5cm x 10cm, eIFU
Lemaitre Vascular, Inc.
e5P10
In Commercial Distribution

  • 00840663108824 ()
e5P10

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 12cm x 25cm
Lemaitre Vascular, Inc.
12BV25
In Commercial Distribution

  • 00840663108800 ()
12BV25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 5cm x 10cm
Lemaitre Vascular, Inc.
5BV10
In Commercial Distribution

  • 00840663108794 ()
5BV10

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 2.5cm x 15cm
Lemaitre Vascular, Inc.
2.5BV15
In Commercial Distribution

  • 00840663108787 ()
2.5BV15

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 12cm x 25cm
Lemaitre Vascular, Inc.
12P25
In Commercial Distribution

  • 00840663108718 ()
12P25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 5cm x 10cm
Lemaitre Vascular, Inc.
5P10
In Commercial Distribution

  • 00840663108701 ()
5P10

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 2.5cm x 15cm
Lemaitre Vascular, Inc.
2.5P15
In Commercial Distribution

  • 00840663108695 ()
2.5P15

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1.5cm x 10cm, eIFU
Lemaitre Vascular, Inc.
e1.5P10
In Commercial Distribution

  • 00840663107414 ()
e1.5P10

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 6cm x 8cm, eIFU
Lemaitre Vascular, Inc.
e6P8
In Commercial Distribution

  • 00840663106806 ()
e6P8

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 0.6cmx8cm
Lemaitre Vascular, Inc.
0.6BV8
In Commercial Distribution

  • 00840663106745 ()


  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cm x 14cm, eIFU
Lemaitre Vascular, Inc.
e1P14
In Commercial Distribution

  • 00840663106356 ()
e1P14

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 10cm x 16cm, eIFU
Lemaitre Vascular, Inc.
e10P16
In Commercial Distribution

  • 00840663106349 ()
e10P16

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 8cm x 14cm, eIFU
Lemaitre Vascular, Inc.
e8P14
In Commercial Distribution

  • 00840663106332 ()
e8P14

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 4cm x 6cm, eIFU
Lemaitre Vascular, Inc.
e4P6
In Commercial Distribution

  • 00840663106325 ()
e4P6

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 4cm x 4cm, eIFU
Lemaitre Vascular, Inc.
e4P4
In Commercial Distribution

  • 00840663106318 ()
e4P4

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 2cm x 9cm, eIFU
Lemaitre Vascular, Inc.
e2P9
In Commercial Distribution

  • 00840663106301 ()
e2P9

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 0.8cm x 8cm, eIFU
Lemaitre Vascular, Inc.
e0.8P8
In Commercial Distribution

  • 00840663106295 ()
e0.8P8

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cm x 6cm
Lemaitre Vascular, Inc.
e1P6
In Commercial Distribution

  • 00840663106288 ()
e1P6

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cmx10cm
Lemaitre Vascular, Inc.
1BV10
In Commercial Distribution

  • 00840663106097 ()


  • Cardiovascular patch, animal-derived
XenoSure Biologic Pledgets, 0.5cm x 1.0cm
Lemaitre Vascular, Inc.
PL0510R25
In Commercial Distribution

  • 00840663109357 ()
PL0510R25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Pledgets, 0.5cm x 0.6cm, 25-Count
Lemaitre Vascular, Inc.
PL0506R25
In Commercial Distribution

  • 00840663109340 ()
PL0506R25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Pledgets, 0.3cm x 0.7cm
Lemaitre Vascular, Inc.
PL0307R25
In Commercial Distribution

  • 00840663109333 ()
PL0307R25

  • Cardiovascular patch, animal-derived
XenoSure Thick Biologic Patch, 10 x 16cm - eP
Lemaitre Vascular, Inc.
e10P16T
In Commercial Distribution

  • 00840663109227 ()
e10P16T

  • Cardiovascular patch, animal-derived
XenoSure Thick Biologic Patch, 6 x 8cm - eP
Lemaitre Vascular, Inc.
e6P8T
In Commercial Distribution

  • 00840663109210 ()
e6P8T

  • Cardiovascular patch, animal-derived
Zip Pen Extension Nozzle 5.2" (13.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2560J
In Commercial Distribution

  • 10614559105757 ()
  • 50614559105755 ()
  • 30614559105751 ()
2560J

  • Surgical plume evacuation system
Zip Pen Extension Nozzle 2.7" (6.8 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2540J
In Commercial Distribution

  • 10614559105320 ()
  • 30614559105324 ()
  • 50614559105328 ()
2540J

  • Surgical plume evacuation system
primaLOK FF 45mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1145-00
In Commercial Distribution

  • 00813210021990 ()

  • Length: 45 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK FF 40mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1140-00
In Commercial Distribution

  • 00813210021983 ()

  • Length: 40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK FF 35mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1135-00
In Commercial Distribution

  • 00813210021976 ()

  • Length: 35 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK FF 30mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1130-00
In Commercial Distribution

  • 00813210021969 ()

  • Length: 30 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK FF 25mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1125-00
In Commercial Distribution

  • 00813210021952 ()

  • Length: 25 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK SP 28mm Medium Boxless Implant, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0828-00
In Commercial Distribution

  • 00813210021785 ()

  • Width: 28 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
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