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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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Exodus - H965105900

Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10590
In Commercial Distribution

  • H965105901 ()
  • H965105900 ()
  • 15051684022866 ()

  • Length: 35 Centimeter
  • Outer Diameter: 2.7 Millimeter
  • Catheter Gauge: 8 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105810

Array Multipurpose Drainage Catheter 10F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10580
In Commercial Distribution

  • H965105811 ()
  • H965105810 ()
  • 15051684022859 ()

  • Length: 35 Centimeter
  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105800

Array Multipurpose Drainage Catheter 8F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10580
In Commercial Distribution

  • H965105801 ()
  • H965105800 ()
  • 15051684022842 ()

  • Catheter Gauge: 8 French
  • Length: 35 Centimeter
  • Outer Diameter: 2.7 Millimeter


  • Closed-wound drain, non-bioabsorbable

ENVI - H965481040

NEEDLE 18G X 15CM CHIBA STYLET ECHO TIP
NAVILYST MEDICAL, INC.
48-104
In Commercial Distribution

  • H965481040 ()
  • H965481041 ()
  • 15051684023788 ()

  • Needle Gauge: 18 Gauge
  • Lumen/Inner Diameter: 0.95 Millimeter
  • Length: 15 Centimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965481030

NEEDLE 21G X 15CM TROCAR STYLET ECHO TIP
NAVILYST MEDICAL, INC.
48-103
In Commercial Distribution

  • H965481031 ()
  • H965481030 ()
  • 15051684023771 ()

  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

ENVI - H965481020

NEEDLE, 21G X 15CM CHIBA STYLET ECHO TIP
NAVILYST MEDICAL, INC.
48-102
In Commercial Distribution

  • H965481020 ()
  • H965481021 ()
  • 15051684023764 ()

  • Needle Gauge: 21 Gauge
  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965481010

GUIDEWIRE, 0.018 X 65CM Ni/Tu
NAVILYST MEDICAL, INC.
48-101
Not in Commercial Distribution

  • H965481010 ()
  • H965481011 ()
  • 15051684023757 ()

  • Length: 65 Centimeter
  • Outer Diameter: 0.018 Inch


  • Vascular catheter introduction set, nonimplantable

ENVI - H965481000

NVI SHEATH 6F X 20CM
NAVILYST MEDICAL, INC.
48-100
In Commercial Distribution

  • H965481000 ()
  • H965481001 ()
  • 15051684023740 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

BioFlo - H965468100

BioFlo Midline with ENDEXO Technology MST-45 Kit
NAVILYST MEDICAL, INC.
46810
In Commercial Distribution

  • H965468100 ()
  • 15051684025379 ()

  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter


  • Peripheral intravenous cannula

BioFlo - H965467100

BioFlo Midline with ENDEXO Technology MST-45 Kit
NAVILYST MEDICAL, INC.
46710
In Commercial Distribution

  • H965467100 ()
  • 15051684025362 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
  • Outer Diameter: 1.68 Millimeter


  • Peripheral intravenous cannula
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