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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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Instrapac Dunhill Artery Forceps Curved 12.5cm X 50
ROBINSON HEALTHCARE LIMITED
8241
In Commercial Distribution

  • 05010058182417 ()
  • 05010058082410 ()

  • Length: 12.5 Centimeter
8241

  • Surgical soft-tissue manipulation forceps, scissors-like, single-use
Instrapac Dunhill Artery Forceps Straight 12.5cm X 50
ROBINSON HEALTHCARE LIMITED
8240
In Commercial Distribution

  • 05010058182400 ()
  • 05010058082403 ()

  • Length: 12.5 Centimeter
8240

  • Surgical soft-tissue manipulation forceps, scissors-like, single-use
Instrapac Spencer Wells Artery Forceps Straight 15cm X 20
ROBINSON HEALTHCARE LIMITED
8244
In Commercial Distribution

  • 05010058182448 ()
  • 05010058082441 ()

  • Length: 15 Centimeter
8244

  • Surgical soft-tissue manipulation forceps, scissors-like, single-use
Instrapac Kocher Artery Forceps Straight 15.5cm X 20
ROBINSON HEALTHCARE LIMITED
8242
In Commercial Distribution

  • 05010058182424 ()
  • 05010058082427 ()

  • Length: 15.5 Centimeter
8242

  • Surgical soft-tissue manipulation forceps, scissors-like, single-use
Instrapac Spencer Wells Artery Forceps Straight 12.5cm X 20
ROBINSON HEALTHCARE LIMITED
7908
In Commercial Distribution

  • 05010058179080 ()
  • 05010058079083 ()

  • Length: 12.5 Centimeter
7908

  • Surgical soft-tissue manipulation forceps, scissors-like, single-use
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
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
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
Celt ACD Vascular Closure Device 5F
VASORUM LIMITED
KCLT-05
In Commercial Distribution

  • 05391530280006 ()
  • 05391530280013 ()
  • 05391530280020 ()

  • Catheter Gauge: 5 French


  • Implantable vascular closure clip
Celt ACD PLUS Vascular Closure Device 7F (US)
VASORUM LIMITED
CLT-07
In Commercial Distribution

  • 05391530280679 ()
  • 05391530280686 ()
  • 05391530280693 ()

  • Catheter Gauge: 7 French


  • Implantable vascular closure clip
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