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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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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
No Description
Hancock Jaffe Laboratories, Inc.
HJL016-40-N
In Commercial Distribution

  • 00866271000039 ()

  • Length: 40 Centimeter
  • Lumen/Inner Diameter: 6 Millimeter


  • Arteriovenous shunt
No Description
Hancock Jaffe Laboratories, Inc.
HJL016-25-N
In Commercial Distribution

  • 00866271000015 ()

  • Length: 25 Centimeter
  • Lumen/Inner Diameter: 6 Millimeter


  • Arteriovenous shunt
Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel B US
STIMWAVE TECHNOLOGIES INCORPORATED
FR4A-TRL-B0
In Commercial Distribution

  • 00859619004936 ()

  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter
  • Weight: 0.25 Gram
S4T-1B US

  • Analgesic spinal cord electrical stimulation system
Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel B US
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-TRL-B0
In Commercial Distribution

  • 00859619004929 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter
S8T-1B US

  • Analgesic spinal cord electrical stimulation system
Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel A US
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-TRL-A0
In Commercial Distribution

  • 00859619004912 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter
S8T-1A US

  • Analgesic spinal cord electrical stimulation system
Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel B US
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-RCV-B0
In Commercial Distribution

  • 00859619004882 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter
S8R-1B US

  • Analgesic spinal cord electrical stimulation system
Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel A US
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-RCV-A0
In Commercial Distribution

  • 00859619004875 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter
S8R-1A US

  • Analgesic spinal cord electrical stimulation system
Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel B US
STIMWAVE TECHNOLOGIES INCORPORATED
FR4A-RCV-B0
In Commercial Distribution

  • 00859619004103 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter
S4R-1B US

  • Analgesic spinal cord electrical stimulation system
Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel A US
STIMWAVE TECHNOLOGIES INCORPORATED
FR4A-TRL-A0
In Commercial Distribution

  • 00859619004097 ()

  • Outer Diameter: 1.35 Millimeter
  • Weight: 0.25 Gram
  • Length: 45 Centimeter
S4T-1A US

  • Analgesic spinal cord electrical stimulation system
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