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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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Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 2.76mm x ID 1.90mm x 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.7x70mm,1.4x70mm, stopcock, syringe, scalpel.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680152
In Commercial Distribution

  • 50886333601528 ()
  • 00886333601523 ()

  • Catheter 6Fr
680152

  • Haemostasis valve
Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.02mm x ID 2.28mm x 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.7x70mm,1.4x70mm, stopcock, syringe, scalpel.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680148
In Commercial Distribution

  • 50886333601481 ()
  • 00886333601486 ()

  • Catheter 7Fr
680148

  • Haemostasis valve
BRONCHOSCOPE-TUBE ID 13MM OD 15.2mm, TL 354mm, for use with the optical element 82510.1400 and head systems 825101100 and 825101200, with distal viewing window, graduated, reusable
Richard Wolf GmbH
825201041
Not in Commercial Distribution

  • 04055207033777 ()

  • Lumen/Inner Diameter: 13 Millimeter
82520.1041

  • Bronchoscopy tube
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
No Description
Merit Medical
00884450284650
In Commercial Distribution

  • 10884450284657 ()
  • 00884450284650 ()

  • Sheath Length (cm)-62 cm
  • Sheath Inner Diameter (ID) (F)-5.5F
  • French Size (F)-5.5F
WORLVI-75-5-62-55-RE

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450284643
In Commercial Distribution

  • 10884450284640 ()
  • 00884450284643 ()

  • Sheath Length (cm)-62 cm
  • French Size (F)-5.5F
  • Sheath Inner Diameter (ID) (F)-5.5F
WORLVI-75-5-62-55-MP

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450284636
In Commercial Distribution

  • 10884450284633 ()
  • 00884450284636 ()

  • French Size (F)-5.5F
  • Sheath Length (cm)-62 cm
  • Sheath Inner Diameter (ID) (F)-5.5F
WORLVI-75-5-62-55-HS

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450284582
In Commercial Distribution

  • 10884450284589 ()
  • 00884450284582 ()

  • Sheath Inner Diameter (ID) (F)-5.5F
  • Sheath Length (cm)-62 cm
  • French Size (F)-5.5F
WORLVI-75-5-62-55-HO

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450169827
In Commercial Distribution

  • 10884450169824 ()
  • 00884450169827 ()

  • French Size (F)-7F
  • Sheath Length (cm)-62 cm
  • Sheath Inner Diameter (ID) (F)-7F
WORLVI-75-5-62-07-MP

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450169810
In Commercial Distribution

  • 10884450169817 ()
  • 00884450169810 ()

  • Sheath Length (cm)-62 cm
  • Sheath Inner Diameter (ID) (F)-7F
  • French Size (F)-7F
WORLVI-75-5-62-07-HO

  • Vascular catheter introduction set, nonimplantable
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