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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 - 00085412530925

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

Supple Peri-Guard - 00085412530710

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 - 00085412530697

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 - 00085412530673

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 - 00085412530642

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 - 00085412530628

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 - 00085412530604

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 - 00085412530581

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 - 00085412530567

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

Biotronik BioEnvelope - 04035479160555

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

Biotronik BioEnvelope - 04035479160548

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

Biotronik BioEnvelope - 04035479160531

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

Biotronik BioEnvelope - 04035479160524

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

Biotronik BioEnvelope - 04035479160517

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

EluPro Antibiotic-Eluting BioEnvelope - 00859389005348

The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.
AZIYO BIOLOGICS, INC.
CMCV-124-LRG
In Commercial Distribution

  • 00859389005348 ()
  • 10859389005345 ()

  • Large


  • Cardiovascular patch, animal-derived

EluPro Antibiotic-Eluting BioEnvelope - 00859389005331

The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.
AZIYO BIOLOGICS, INC.
CMCV-124-MED
In Commercial Distribution

  • 00859389005331 ()
  • 10859389005338 ()

  • Medium


  • Cardiovascular patch, animal-derived

SYNFIX Evolution - 10705034814193

SYNFIX® EVOLUTION IMPLANT PACKING STATION
Synthes GmbH
03.835.050
In Commercial Distribution

  • 07611819658172 ()
  • H981038350500 ()
  • 10705034814193 ()
03835050

  • Bone graft packing block

NA - 10705034732350

GRAFT PACKING BLOCK
Synthes GmbH
03.841.055
In Commercial Distribution

  • 07611819473140 ()
  • H981038410550 ()
  • 10705034732350 ()
03841055

  • Bone graft packing block

SynCage - 10705034732053

GRAFT PACKING BLOCK-LARGE FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.074
In Commercial Distribution

  • 07611819534780 ()
  • H981038250740 ()
  • 10705034732053 ()
03825074

  • Bone graft packing block

SynCage - 10705034732046

GRAFT PACKING BLOCK-MEDIUM FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.073
In Commercial Distribution

  • 07611819534773 ()
  • H981038250730 ()
  • 10705034732046 ()
03825073

  • Bone graft packing block

SynCage - 10705034732039

GRAFT PACKING BLOCK-SMALL FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.072
In Commercial Distribution

  • 07611819534766 ()
  • H981038250720 ()
  • 10705034732039 ()
03825072

  • Bone graft packing block

SynFix-LR - 10705034722276

PACKING BLOCK FOR 30MM DEPTH/ 38MM WIDTH SYNFIX(TM)-LR
SYNTHES (U.S.A.) LP
03.802.042
Not in Commercial Distribution

  • 07611819297425 ()
  • H981038020420 ()
  • 10705034722276 ()
03802042

  • Bone graft packing block

SynFix-LR - 10705034722269

PACKING BLOCK FOR 26MM DEPTH/ 32MM WIDTH SYNFIX(TM)-LR
SYNTHES (U.S.A.) LP
03.802.041
Not in Commercial Distribution

  • 07611819791268 ()
  • H981038020410 ()
  • 10705034722269 ()
03802041

  • Bone graft packing block

Zero-P VA - 10705034720838

PACKING BLOCK FOR ZERO-P VA IMPLANTS
Synthes GmbH
03.647.984
In Commercial Distribution

  • 07611819404502 ()
  • H981036479840 ()
  • 10705034720838 ()
03647984

  • Bone graft packing block

NA - 10705034717388

PACKING BLOCK FOR ZERO-P IMPLANTS
Synthes GmbH
03.617.984
In Commercial Distribution

  • 07611819969780 ()
  • H981036179840 ()
  • 10705034717388 ()
03617984

  • Bone graft packing block

NA - 10705034778204

ACF GRAFT PACKING BLOCK
Synthes GmbH
396.996
In Commercial Distribution

  • H9813969960 ()
  • 10705034778204 ()
396996

  • Bone graft packing block

ALIF - 10705034774800

ALIF GRAFT PACKING BLOCK
Synthes GmbH
389.155
In Commercial Distribution

  • H9813891550 ()
  • 10705034774800 ()
389155

  • Bone graft packing block

OCELOT - 10705034189727

OCELOT STACKABLE CAGE SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
273400900
In Commercial Distribution

  • 10705034189727 ()
273400900

  • Bone graft packing block

BENGAL - 10705034188065

BENGAL SYSTEM BONE FILLER BLOCK, EXTRA LARGE
DEPUY SPINE, LLC
273310301
In Commercial Distribution

  • 10705034188065 ()
273310301

  • Bone graft packing block

BENGAL - 10705034188058

BENGAL SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
273310300
In Commercial Distribution

  • 10705034188058 ()
273310300

  • Bone graft packing block
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