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.
VG0106
In Commercial Distribution

  • 00085412818474 ()
VG0106

  • Cardiovascular patch, animal-derived
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. 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.
PG0608
In Commercial Distribution

  • 00085412818443 ()
PG0608

  • 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.
SPG1016
In Commercial Distribution

  • 00085412818429 ()
SPG1016

  • Cardiovascular patch, animal-derived
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. 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.
PG0404
In Commercial Distribution

  • 00085412818405 ()
PG0404

  • 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.
SPG0814
In Commercial Distribution

  • 00085412818375 ()
SPG0814

  • 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.
SPG0608
In Commercial Distribution

  • 00085412818313 ()
SPG0608

  • 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
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
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