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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 - H965100020

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

Exodus - H965100010

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

BioFlo - H956PKM61014921S0

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

BioFlo - H954PKM033511S0

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 - J014002112140011

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

PALACOS - J014001119140011

PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin. PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G 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
LV+G
Not in Commercial Distribution

  • J014001119140011 ()
  • J014001119140012 ()
00-1119-140-01

  • Orthopaedic cement, non-antimicrobial

PALACOS - J014001118140011

PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS® LV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field it 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
LV
Not in Commercial Distribution

  • J014001118140011 ()
  • J014001118140012 ()
00-1118-140-01

  • Orthopaedic cement, non-antimicrobial

PALACOS - J014001113140011

PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.
Heraeus Medical GmbH
R+G
Not in Commercial Distribution

  • J014001113140011 ()
  • J014001113140012 ()
00-1113-140-01

  • Orthopaedic cement, non-antimicrobial

NAMIC - H965640393080

Perceptor Manifold High Pressure
NAVILYST MEDICAL, INC.
64039308
In Commercial Distribution

  • H965640393081 ()
  • H965640393080 ()

  • Length: 48 Inch


  • Invasive-pressure external transducer, single-use

NAMIC - H965640384040

NAMIC Angiographic Medium Pressure 4 Valve Manifold, On Star Handles, Ports on Right
NAVILYST MEDICAL, INC.
64038404
In Commercial Distribution

  • H965640384041 ()
  • H965640384040 ()


  • Stopcock
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