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 Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0106N
In Commercial Distribution

  • 00085412530871 ()
VG0106N

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016SN
In Commercial Distribution

  • 00085412530710 ()
PC1016SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814SN
In Commercial Distribution

  • 00085412530697 ()
PC0814SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608SN
In Commercial Distribution

  • 00085412530673 ()
PC0608SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404SN
In Commercial Distribution

  • 00085412530642 ()
PC0404SNBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1225N
In Commercial Distribution

  • 00085412530628 ()
PC1225NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016N
In Commercial Distribution

  • 00085412530604 ()
PC1016NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814N
In Commercial Distribution

  • 00085412530581 ()
PC0814NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608N
In Commercial Distribution

  • 00085412530567 ()
PC0608NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404N
In Commercial Distribution

  • 00085412530529 ()
PC0404NBIO

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
GENESEE BIOMEDICAL, INC.
PFP6x8
In Commercial Distribution

  • B040PFP6X81 ()
N/A

  • 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
IMPACTOR X807-914 ANGLED GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
X807-914
In Commercial Distribution

  • 00673978158327 ()


  • Bone graft packing block
THREADED GRAFT SQUARE
MEDTRONIC SOFAMOR DANEK, INC.
X0596-011
In Commercial Distribution

  • 00673978140513 ()


  • Bone graft packing block
THREADED GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0596-010
In Commercial Distribution

  • 00673978140506 ()


  • Bone graft packing block
Screw Sizing Block
Seaspine Orthopedics Corporation
90-0530
In Commercial Distribution

  • 10889981128876 ()
90-0530

  • Bone graft packing block
Graft Packing Block, 18mm
Seaspine Orthopedics Corporation
95-6091
In Commercial Distribution

  • 10889981097783 ()

  • 18mm
95-6091

  • Bone graft packing block
Implant Packing Block
Seaspine Orthopedics Corporation
86-0070
In Commercial Distribution

  • 10889981127121 ()
86-0070

  • Bone graft packing block
Graft Block
Seaspine Orthopedics Corporation
31-40-0142
In Commercial Distribution

  • 10889981121471 ()
31-40-0142

  • Bone graft packing block
Graft Packing Block, 38mm x 26mm
Seaspine Orthopedics Corporation
95-5193
In Commercial Distribution

  • 10889981120627 ()

  • 38mm x 26mm
95-5193

  • Bone graft packing block
Graft Packing Block
Seaspine Orthopedics Corporation
14-40-0101
In Commercial Distribution

  • 10889981109059 ()
14-40-0101

  • Bone graft packing block
Rotation Block
Seaspine Orthopedics Corporation
10-40-0330
In Commercial Distribution

  • 10889981106638 ()
10-40-0330

  • Bone graft packing block
Graft Block
Seaspine Orthopedics Corporation
33-40-0141
In Commercial Distribution

  • 10889981125882 ()
33-40-0141

  • Bone graft packing block
Zuma-C Universal Graft Packing Block
Seaspine Orthopedics Corporation
95-7092
In Commercial Distribution

  • 10889981120733 ()

  • N/A
95-7092

  • Bone graft packing block
Rotation Block
Seaspine Orthopedics Corporation
25-40-0330
In Commercial Distribution

  • 10889981114800 ()
25-40-0330

  • Bone graft packing block
Screw Sizing Block
Seaspine Orthopedics Corporation
25-40-0165
In Commercial Distribution

  • 10889981114640 ()
25-40-0165

  • Bone graft packing block
Graft Block
Seaspine Orthopedics Corporation
21-40-0140
In Commercial Distribution

  • 10889981111472 ()
21-40-0140

  • Bone graft packing block
Graft Packing Block
Seaspine Orthopedics Corporation
15-40-0300
In Commercial Distribution

  • 10889981109103 ()
15-40-0300

  • Bone graft packing block
Graft Packer Block
Seaspine Orthopedics Corporation
11-40-0101
In Commercial Distribution

  • 10889981106874 ()
11-40-0101

  • Bone graft packing block
Graft Packing Block
Seaspine Orthopedics Corporation
95-7091
In Commercial Distribution

  • 10889981100223 ()

  • N/A
95-7091

  • Bone graft packing block
Graft Packing Block, 32mm x 25mm
Seaspine Orthopedics Corporation
95-5192
In Commercial Distribution

  • 10889981096533 ()

  • 32mm x 25mm
95-5192

  • Bone graft packing block
Graft Packing Block, 26mm x 24mm
Seaspine Orthopedics Corporation
95-5191
In Commercial Distribution

  • 10889981096526 ()

  • 26mm x 24mm
95-5191

  • Bone graft packing block
Graft Block
Seaspine Orthopedics Corporation
TO2-006000
In Commercial Distribution

  • 10889981195755 ()
TO2-006000

  • Bone graft packing block
Packing Block
Seaspine Orthopedics Corporation
86-0072
In Commercial Distribution

  • 10889981143336 ()
86-0072

  • Bone graft packing block
Shoreline/Admiral Graft Packer
Seaspine Orthopedics Corporation
SR-0755
In Commercial Distribution

  • 10889981285364 ()
SR-0755

  • Bone graft packing block
Graft Block
Seaspine Orthopedics Corporation
RA2-006003
In Commercial Distribution

  • 10889981216535 ()
RA2-006003

  • Bone graft packing block
Graft Block
Seaspine Orthopedics Corporation
TA2-006000
In Commercial Distribution

  • 10889981213022 ()
TA2-006000

  • Bone graft packing block
Graft Block
Seaspine Orthopedics Corporation
36-90-3061
In Commercial Distribution

  • 10889981162368 ()
36-90-3061

  • Bone graft packing block
Graft Block
Seaspine Orthopedics Corporation
33-40-0142
In Commercial Distribution

  • 10889981160067 ()
33-40-0142

  • Bone graft packing block
VENTURA NM GRAFT PACKER
Seaspine Orthopedics Corporation
SR-0229
In Commercial Distribution

  • 10889981157609 ()
SR-0229

  • Bone graft packing block
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