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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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Decellularized Bovine Pericardium
Artivion, Inc.
PFP6X8
In Commercial Distribution


  • Width: 6 Centimeter
  • Length: 8 Centimeter
PFP6X8

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP8X14
In Commercial Distribution

  • 00877234000560 ()

  • Width: 8 Centimeter
  • Length: 14 Centimeter
PFP8X14

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP0.8X8
In Commercial Distribution

  • 00877234000553 ()

  • Width: 0.8 Centimeter
  • Length: 8 Centimeter
PFP0.8X8

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP4X4
In Commercial Distribution

  • 00877234000546 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter
PFP4X4

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP 6x8
In Commercial Distribution


  • Width: 6 Centimeter
  • Length: 8 Centimeter
PFP 6x8

  • Cardiovascular patch, animal-derived
CryoPatch SG Pulmonary Trunk The CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGP010
In Commercial Distribution

  • 00877234000478 ()

  • Width: 3.0cm (minimum)(allograft specific)
  • Length: 12.5cm (minimum)(allograft specific)
SGP010

  • Cadaveric pulmonary artery bioprosthesis
The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. The HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of a proprietary Venous Outflow Component and only one of the following options: • The Arterial Graft Component (not included) • The Adapter (a separate commercially available 6mm ID vascular graft is not included with the Adapter) The Venous Outflow Component (not included) has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip. The Adapter connects a 6mm ID vascular graft (not included) to the Venous Outflow Component. The Adapter (titanium) has a tapered ID (6mm to 5mm) to provide a smooth transition from a 6mm ID vascular graft to the 5mm ID Venous Outflow Component. A disposable Graft Expander is provided to aid in connecting a 6mm ID vascular graft to the Adapter. See Instructions for Use for further details regarding the grafts permitted for use with the Adapter.
Artivion, Inc.
HERO 1004
Not in Commercial Distribution

  • 00877234000423 ()
HERO 1004

  • Arteriovenous shunt
10 mL Syringe, Standard Applicator Tips, and Syringe Spreader Tips
Artivion, Inc.
BG3510-5-US
Not in Commercial Distribution

  • 10877234000253 ()
  • 00877234000256 ()

  • Total Volume: 10 Milliliter
BG3510-5-US

  • Surgical internal adhesive/sealant, animal-derived
2mL Syringe and Standard Applicator Tips
Artivion, Inc.
BG3502-5-US
Not in Commercial Distribution

  • 00877234000232 ()
  • 10877234000239 ()

  • Total Volume: 2 Milliliter
BG3502-5-US

  • Surgical internal adhesive/sealant, animal-derived
6F x 60 cm Triple Lumen Synergy CT PICC IR Kit
Health Line International Corporation
A14-06360-IR-03
In Commercial Distribution

  • 10876604004808 ()
  • 00876604004801 ()
  • 20876604004805 ()
A14-06360-IR

  • Peripherally-inserted central venous catheter
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