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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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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
8F x 25cm Tight Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10003
Not in Commercial Distribution

  • H965100031 ()
  • H965100030 ()

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


  • Closed-wound drain, non-bioabsorbable
8F x 25cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10002
Not in Commercial Distribution

  • H965100021 ()
  • H965100020 ()

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


  • Closed-wound drain, non-bioabsorbable
8F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10001
Not in Commercial Distribution

  • H965100011 ()
  • H965100010 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 20 Centimeter


  • Closed-wound drain, non-bioabsorbable
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM61014921S
In Commercial Distribution

  • H965PKM61014921S1 ()
  • H956PKM61014921S0 ()

  • Single
  • Catheter Gauge: 4 French
  • Length: 55 Centimeter


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM033511S
In Commercial Distribution

  • H965PKM033511S1 ()
  • H954PKM033511S0 ()

  • Dual
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French


  • Peripherally-inserted central venous catheter
PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Heraeus Medical GmbH
R
Not in Commercial Distribution

  • J014002112140011 ()
  • J014001112140012 ()
00-1112-140-01

  • Orthopaedic cement, non-antimicrobial
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