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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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Endodontic instruments for professionnal use only
MICRO MEGA
n008 L21
In Commercial Distribution

  • J015201020049 ()
  • J015201020041 ()
  • J015201020040 ()
20102004

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n006 L25
In Commercial Distribution

  • J015201020029 ()
  • J015201020021 ()
  • J015201020020 ()
20102002

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n006 L21 ISO M09
In Commercial Distribution

  • J015201020011 ()
  • J015201020012 ()
  • J015201020010 ()
20102001

  • Manual endodontic file/rasp, reusable
GUIDEWIRE, 0.018 X 65CM Ni/Tu
NAVILYST MEDICAL, INC.
48-108
In Commercial Distribution

  • H965481080 ()
  • H965481081 ()
  • 15051684023795 ()

  • Outer Diameter: 0.018 Inch
  • Length: 65 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
GUIDEWIRE, 1.5MM J-.035-80-R0SEN-PTFE
NAVILYST MEDICAL, INC.
48-107
In Commercial Distribution

  • H965481070 ()
  • H965481071 ()

  • Outer Diameter: 0.035 Inch
  • Length: 80 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
GUIDEWIRE, 1.5MM J-.038-150-ROSEN-PTFE
NAVILYST MEDICAL, INC.
48-106
In Commercial Distribution

  • H965481060 ()
  • H965481061 ()

  • Length: 150 Centimeter
  • Outer Diameter: 0.038 Inch


  • Cardiac/peripheral vascular guidewire, single-use
GUIDEWIRE, 1.5MM J-.038-80-ROSEN-PTFE
NAVILYST MEDICAL, INC.
48-105
In Commercial Distribution

  • H965481050 ()
  • H965481051 ()

  • Outer Diameter: 0.038 Inch
  • Length: 80 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
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
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
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
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