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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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15.5Fx48cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
02-823
In Commercial Distribution

  • H965103028230 ()
  • 15051684025645 ()

  • Outer Diameter: 5.2 Millimeter
  • Catheter Gauge: 15.5 French
  • Length: 48 Centimeter


  • Double-lumen haemodialysis catheter, implantable
15.5Fx40cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
02-822
In Commercial Distribution

  • H965103028220 ()
  • 15051684025638 ()

  • Length: 40 Centimeter
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter


  • Double-lumen haemodialysis catheter, implantable
15.5Fx55cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-809
In Commercial Distribution

  • H965103028090 ()
  • 15051684025461 ()

  • Catheter Gauge: 15.5 French
  • Length: 55 Centimeter
  • Needle Gauge: 18 Gauge
  • Outer Diameter: 5.2 Millimeter


  • Double-lumen haemodialysis catheter, implantable
15.5Fx48cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-808
In Commercial Distribution

  • H965103028080 ()
  • 15051684025454 ()

  • Length: 48 Centimeter
  • Outer Diameter: 5.2 Millimeter
  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
15.5Fx40cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-807
In Commercial Distribution

  • H965103028070 ()
  • 15051684025447 ()

  • Length: 40 Centimeter
  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter


  • Double-lumen haemodialysis catheter, implantable
Alatus Vaginal Balloon Packing System
ANGIODYNAMICS, INC.
VBP-40
In Commercial Distribution

  • 15051684018913 ()
  • H787VBP400 ()


  • Radiation therapy lesion localization urethral catheter, planning
Vortex TR Single Titanium Port System with Attachable 9.6F x 70cm Silicone Catheter
NAVILYST MEDICAL, INC.
SSDX-16-I
In Commercial Distribution

  • H787SSDX16I0 ()
  • 15051684018463 ()

  • Length: 70 Centimeter
  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 9.6 French
  • Outer Diameter: 3.2 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter


  • Vascular port/catheter
Vortex TR Single Titanium Port System with Attachable 7.5F x 70cm Silicone Catheter
NAVILYST MEDICAL, INC.
SSDX-14-I
In Commercial Distribution

  • H787SSDX14I0 ()
  • 15051684018456 ()

  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 7.5 French
  • Length: 70 Centimeter
  • Lumen/Inner Diameter: 1.4 Millimeter
  • Outer Diameter: 2.5 Millimeter


  • Vascular port/catheter
Vortex TR Single Titanium Port System with Attachable 6.6F x 70cm Silicone Catheter
NAVILYST MEDICAL, INC.
SSDX-10-I
In Commercial Distribution

  • H787SSDX10I0 ()
  • 15051684018449 ()

  • Needle Gauge: 18 Gauge
  • Length: 70 Centimeter
  • Catheter Gauge: 6.6 French
  • Lumen/Inner Diameter: 1 Millimeter
  • Outer Diameter: 2.2 Millimeter


  • Vascular port/catheter
Vortex TR Single Titanium Port System with Attached 9.6F x 53cm Silicone Catheter
NAVILYST MEDICAL, INC.
SSAX-16-I
In Commercial Distribution

  • H787SSAX16I0 ()
  • 15051684018432 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Length: 53 Centimeter
  • Needle Gauge: 18 Gauge
  • Outer Diameter: 3.2 Millimeter
  • Catheter Gauge: 9.6 French


  • Vascular port/catheter
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