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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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, 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
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
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
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.
VG0209N
In Commercial Distribution

  • 00085412530925 ()
VG0209N

  • Cardiovascular patch, animal-derived
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.
VG0110N
In Commercial Distribution

  • 00085412530918 ()
VG0110N

  • Cardiovascular patch, animal-derived
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.
VG0108N
In Commercial Distribution

  • 00085412530895 ()
VG0108N

  • Cardiovascular patch, animal-derived
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
SUPPLE PERI-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. SUPPLE PERI-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.
SPG0406
In Commercial Distribution

  • 00085412818696 ()
SPG0406

  • Cardiovascular patch, animal-derived
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