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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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BioFlo - H965750130

BioFlo PICC with Endexo Technology - 5F x 55 cm Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75013
In Commercial Distribution

  • H965750131 ()
  • H965750130 ()
  • 15051684026611 ()

  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.7 Millimeter
  • Pressure: 325 Pound per Square Inch
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French


  • Peripherally-inserted central venous catheter

Xcela - H965750040

Xcela Power Injectable PICC - 6F x 55cm Dual Lumen Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75004
In Commercial Distribution

  • H965750041 ()
  • H965750040 ()

  • Needle Gauge: 21 Gauge
  • Pressure: 300 Pound per Square Inch
  • Length: 55 Centimeter
  • Catheter Gauge: 6 French
  • Outer Diameter: 1.94 Millimeter


  • Peripherally-inserted central venous catheter

Xcela - H965750030

Xcela Power Injectable PICC - 5F x 55cm Dual Lumen Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75003
In Commercial Distribution

  • H965750031 ()
  • H965750030 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
  • Pressure: 300 Pound per Square Inch
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.73 Millimeter


  • Peripherally-inserted central venous catheter

Xcela - H965750020

Xcela Power Injectable PICC - 5F x 55cm Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75002
In Commercial Distribution

  • H965750021 ()
  • H965750020 ()

  • Needle Gauge: 21 Gauge
  • Pressure: 300 Pound per Square Inch
  • Outer Diameter: 1.68 Millimeter
  • 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

Diamodent - D907P4010

Compatible with: 3.5mm Platform Screw-Vent Zimmer implants Overdenture Abutment, Clear Plastic, Green Non-Hexed
DIAMODENT INC
N/A
In Commercial Distribution

  • D907P4011 ()
  • D907P4010 ()
P401

  • Dental implant suprastructure, permanent, preformed

Diamodent - D907E6550

Compatible with: 3.3mm & 3.4mm Small Diameter (SD) Lifecore / Keystone implants ComScrew, Titanium .050" Hex 20 Ncm
DIAMODENT INC
N/A
In Commercial Distribution

  • D907E6551 ()
  • D907E6550 ()
E655

  • Dental prosthesis/implant abutment screw
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