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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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PhotoFix Decellularized Bovine Pericardium - 00877234000652

Decellularized Bovine Pericardium
Artivion, Inc.
PFP2X9
In Commercial Distribution

  • 00877234000652 ()

  • Width: 2 Centimeter
  • Length: 9 Centimeter
PFP2X9

  • Cardiovascular patch, animal-derived

PhotoFix Decellularized Bovine Pericardium - 00877234000638

Decellularized Bovine Pericardium
Artivion, Inc.
PFP1X10
In Commercial Distribution

  • 00877234000638 ()

  • Width: 1 Centimeter
  • Length: 10 Centimeter
PFP1X10

  • Cardiovascular patch, animal-derived

PhotoFix Decellularized Bovine Pericardium - 00877234000539

Decellularized Bovine Pericardium
Artivion, Inc.
PFP1X6
In Commercial Distribution

  • 00877234000539 ()

  • Width: 1 Centimeter
  • Length: 6 Centimeter
PFP1X6

  • Cardiovascular patch, animal-derived

CryoPatch® SG Pulmonary Human Cardiac Branch Patch - 00877234000485

CryoPatch SG Pulmonary Branch The CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGP020
In Commercial Distribution

  • 00877234000485 ()

  • Width: 3.0cm (minimum)(allograft specific)
  • Length: 12.5cm (minimum)(allograft specific)
SGP020

  • Cadaveric pulmonary artery bioprosthesis

CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch - 00877234000461

CryoPatch SG Pulmonary Hemi-Artery The CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPH00
In Commercial Distribution

  • 00877234000461 ()

  • Branch Length: 1.0cm (minimum) (allograft specific)
  • Proximal Base: 30mm (minimum) (allograft specific)
SGPH00

  • Cadaveric pulmonary artery bioprosthesis

BioGlue Surgical Adhesive - 00877234000249

5mL Syringe and Standard Applicator Tips
Artivion, Inc.
BG3515-5-US
Not in Commercial Distribution

  • 00877234000249 ()
  • 10877234000246 ()

  • Total Volume: 5 Milliliter
BG3515-5-US

  • Surgical internal adhesive/sealant, animal-derived

HeRO® Graft Accessory Component Kit - 00877234000089

The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term 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. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of two primary components: • A proprietary Venous Outflow Component • A proprietary Arterial Graft Component The HeRO Graft Accessory Components provides instruments and accessories (such as, peel away sheaths and dilators, stylet, disposable clamp, hemostasis plug and hemostatic Y-valve with stopcock) that may aid in the placement of the HeRO Graft.
Artivion, Inc.
HERO 1003
Not in Commercial Distribution

  • 00877234000089 ()

  • 16 French Dilator, Outer Diameter: 16 French
  • 10 French Stylet, Outer Diameter: 10 French
  • 10 French Stylet, Length: 47 Centimeters
  • 20 F Sheath Introducer & Dilator, Sheath Length: 5.8 Inches
  • 20 F Sheath Introducer & Dilator, Sheath Inner Diameter: 20 French
  • 20 F Sheath Introducer & Dilator, Dilator Length: 7.9 Inches
  • 20 F Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
  • 20 F Short Sheath Introducer & Dilator, Sheath Length: 3.13 Inches
  • 20 F Short Sheath Introducer & Dilator, Sheath Diameter: 20 French
  • 20 F Short Sheath Introducer & Dilator, Dilator Length: 4.75 Inches
  • 20 F Short Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
  • 12 French Dilator, Length: 7.9 Inches
  • 12 French Dilator, Outer Diameter: 12 French
  • 16 French Dilator, Length: 7.9 Inches
HERO 1003

  • Arteriovenous shunt

HeRO® Graft Venous Outflow Component - 00877234000065

The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term 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. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of two primary components: • A proprietary Venous Outflow Component • A proprietary Arterial Graft Component The HeRO Graft Venous Outflow Component 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.
Artivion, Inc.
HERO 1001
Not in Commercial Distribution

  • 00877234000065 ()

  • Outer Diamter: 19 French
  • Lumen/Inner Diameter: 5 Millimeter
  • Length: 40 Centimeter
HERO 1001

  • Arteriovenous shunt

Synergy - 00876604004795

6F x 60 cm Dual Lumen Synergy CT PICC IR Kit
Health Line International Corporation
A14-06260-IR-03
In Commercial Distribution

  • 10876604004792 ()
  • 00876604004795 ()
  • 20876604004799 ()
A14-06260-IR

  • Peripherally-inserted central venous catheter

Synergy - 00876604004771

5F x 60 cm Single Lumen Synergy CT PICC IR Kit
Health Line International Corporation
A14-05160-IR-03
In Commercial Distribution

  • 00876604004771 ()
  • 10876604004778 ()
  • 20876604004775 ()
A14-05160-IR

  • Peripherally-inserted central venous catheter
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