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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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15.5Fx28cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-804
In Commercial Distribution

  • H965103028041 ()
  • H965103028040 ()
  • 15051684025416 ()

  • Needle Gauge: 18 Gauge
  • Length: 28 Centimeter
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter


  • Double-lumen haemodialysis catheter, implantable
15.5Fx24cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-803
In Commercial Distribution

  • H965103028031 ()
  • H965103028030 ()
  • 15051684025409 ()

  • Outer Diameter: 5.2 Millimeter
  • Needle Gauge: 18 Gauge
  • Length: 24 Centimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
15.5Fx22cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-802
In Commercial Distribution

  • H965103028021 ()
  • H965103028020 ()
  • 15051684025393 ()

  • Length: 22 Centimeter
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable
15.5Fx20cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-801
In Commercial Distribution

  • H965103028011 ()
  • H965103028010 ()
  • 15051684025386 ()

  • Needle Gauge: 18 Gauge
  • Length: 20 Centimeter
  • Outer Diameter: 5.2 Millimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
Array Multipurpose Drainage Catheter 10F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10151
In Commercial Distribution

  • H965101511 ()
  • H965101510 ()
  • 15051684022507 ()

  • Outer Diameter: 3.4 Millimeter
  • Length: 25 Centimeter
  • Catheter Gauge: 10 French


  • Closed-wound drain, non-bioabsorbable
Array Multipurpose Drainage Catheter 8F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10143
In Commercial Distribution

  • H965101431 ()
  • H965101430 ()
  • 15051684022491 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 25 Centimeter


  • Closed-wound drain, non-bioabsorbable
Array Multipurpose Drainage Catheter 10F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10052
In Commercial Distribution

  • H965100521 ()
  • H965100520 ()
  • 15051684022484 ()

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


  • Closed-wound drain, non-bioabsorbable
Array Multipurpose Drainage Catheter 8F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10044
In Commercial Distribution

  • H965100441 ()
  • H965100440 ()
  • 15051684022477 ()

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


  • Closed-wound drain, non-bioabsorbable
10F x 35cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10032
Not in Commercial Distribution

  • H965100321 ()
  • H965100320 ()

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


  • Closed-wound drain, non-bioabsorbable
10F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10008
Not in Commercial Distribution

  • H965100081 ()
  • H965100080 ()

  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French
  • Length: 20 Centimeter


  • Closed-wound drain, non-bioabsorbable
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