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 instrument for professional dental use only
MICRO MEGA
n006 L21
In Commercial Distribution

  • J015201040011 ()
  • J015201040019 ()
  • J015201040010 ()
20104001

  • Rotary/reciprocating endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n040 L25
In Commercial Distribution

  • J015201030329 ()
  • J015201030321 ()
  • J015201030320 ()
20103032

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n035 L25
In Commercial Distribution

  • J015201030299 ()
  • J015201030291 ()
  • J015201030290 ()
20103029

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n030 L25
In Commercial Distribution

  • J015201030269 ()
  • J015201030261 ()
  • J015201030260 ()
20103026

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n025 L25
In Commercial Distribution

  • J015201030239 ()
  • J015201030231 ()
  • J015201030230 ()
20103023

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n020 L25
In Commercial Distribution

  • J015201030209 ()
  • J015201030201 ()
  • J015201030200 ()
20103020

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n020 L21
In Commercial Distribution

  • J015201030199 ()
  • J015201030191 ()
  • J015201030190 ()
20103019

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n015 L25
In Commercial Distribution

  • J015201030179 ()
  • J015201030171 ()
  • J015201030170 ()
20103017

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n015 L21
In Commercial Distribution

  • J015201030169 ()
  • J015201030161 ()
  • J015201030160 ()
20103016

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n010 L25
In Commercial Distribution

  • J015201030149 ()
  • J015201030141 ()
  • J015201030140 ()
20103014

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n010 L21
In Commercial Distribution

  • J015201030139 ()
  • J015201030131 ()
  • J015201030130 ()
20103013

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n008 L25
In Commercial Distribution

  • J015201030119 ()
  • J015201030111 ()
  • J015201030110 ()
20103011

  • Manual endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use
MICRO MEGA
n008 L21
In Commercial Distribution

  • J015201030101 ()
  • J015201030109 ()
  • J015201030100 ()
20103010

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n040 L25
In Commercial Distribution

  • J015201020269 ()
  • J015201020261 ()
  • J015201020260 ()
20102026

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n025 L25
In Commercial Distribution

  • J015201020179 ()
  • J015201020171 ()
  • J015201020170 ()
20102017

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n020 L25
In Commercial Distribution

  • J015201020149 ()
  • J015201020141 ()
  • J015201020140 ()
20102014

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n020 L21
In Commercial Distribution

  • J015201020139 ()
  • J015201020131 ()
  • J015201020130 ()
20102013

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n015 L25
In Commercial Distribution

  • J015201020119 ()
  • J015201020111 ()
  • J015201020110 ()
20102011

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n015 L21
In Commercial Distribution

  • J015201020109 ()
  • J015201020101 ()
  • J015201020100 ()
20102010

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n010 L25
In Commercial Distribution

  • J015201020089 ()
  • J015201020081 ()
  • J015201020080 ()
20102008

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n010 L21
In Commercial Distribution

  • J015201020079 ()
  • J015201020071 ()
  • J015201020070 ()
20102007

  • Manual endodontic file/rasp, reusable
Endodontic instruments for professionnal use only
MICRO MEGA
n008 L25
In Commercial Distribution

  • J015201020059 ()
  • J015201020051 ()
  • J015201020050 ()
20102005

  • Manual endodontic file/rasp, reusable
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
GUIDEWIRE, 0.018 X 65CM Ni/Tu
NAVILYST MEDICAL, INC.
48-101
Not in Commercial Distribution

  • H965481010 ()
  • H965481011 ()
  • 15051684023757 ()

  • Length: 65 Centimeter
  • Outer Diameter: 0.018 Inch


  • Vascular catheter introduction set, nonimplantable
NVI SHEATH 6F X 20CM
NAVILYST MEDICAL, INC.
48-100
In Commercial Distribution

  • H965481000 ()
  • H965481001 ()
  • 15051684023740 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
46490
In Commercial Distribution

  • H965464901 ()
  • H965464900 ()
  • 15051684027076 ()

  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French


  • Peripheral intravenous cannula
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
46480
In Commercial Distribution

  • H965464801 ()
  • H965464800 ()
  • 15051684027052 ()

  • Outer Diameter: 1.68 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
  • Catheter Gauge: 5 French


  • Peripheral intravenous cannula
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
46470
In Commercial Distribution

  • H965464701 ()
  • H965464700 ()
  • 15051684027038 ()

  • Catheter Gauge: 4 French
  • Outer Diameter: 1.4 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter


  • Peripheral intravenous cannula
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
46460
In Commercial Distribution

  • H965464601 ()
  • H965464600 ()
  • 15051684027021 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 3 French
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.02 Millimeter


  • Peripheral intravenous cannula
BioFlo Midline with ENDEXO Technology (5F x 20cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
46-029
In Commercial Distribution

  • H965460290 ()
  • H965460291 ()
  • 15051684027014 ()

  • Length: 20 Centimeter
  • Pressure: 172 Pound per Square Inch
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge


  • Peripherally-inserted central venous catheter
BioFlo Midline with ENDEXO Technology (5F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
46-028
In Commercial Distribution

  • H965460280 ()
  • H965460281 ()
  • 15051684027007 ()

  • Length: 20 Centimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.68 Millimeter
  • Pressure: 153 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
46-027
In Commercial Distribution

  • H965460270 ()
  • H965460271 ()
  • 15051684026994 ()

  • Catheter Gauge: 4 French
  • Length: 20 Centimeter
  • Outer Diameter: 1.4 Millimeter
  • Needle Gauge: 21 Gauge
  • Pressure: 181 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo Midline with ENDEXO Technology (3F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
46-026
In Commercial Distribution

  • H965460260 ()
  • H965460261 ()
  • 15051684026987 ()

  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
  • Catheter Gauge: 3 French
  • Outer Diameter: 1.02 Millimeter
  • Pressure: 168 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo Midline with ENDEXO Technology (5F x 20cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
46-025
In Commercial Distribution

  • H965460250 ()
  • H965460251 ()
  • 15051684026970 ()

  • Catheter Gauge: 5 French
  • Pressure: 172 Pound per Square Inch
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.73 Millimeter
  • Length: 20 Centimeter


  • Peripherally-inserted central venous catheter
BioFlo Midline with ENDEXO Technology (5F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
46-024
In Commercial Distribution

  • H965460240 ()
  • H965460241 ()
  • 15051684026963 ()

  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.68 Millimeter
  • Catheter Gauge: 5 French
  • Pressure: 153 Pound per Square Inch
  • Length: 20 Centimeter


  • Peripherally-inserted central venous catheter
BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
46-023
In Commercial Distribution

  • H965460230 ()
  • H965460231 ()
  • 15051684026956 ()

  • Pressure: 181 Pound per Square Inch
  • Catheter Gauge: 4 French
  • Length: 20 Centimeter
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.4 Millimeter


  • Peripherally-inserted central venous catheter
BioFlo Midline with ENDEXO Technology (3F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
46-022
In Commercial Distribution

  • H965460220 ()
  • H965460221 ()
  • 15051684026949 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 3 French
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.02 Millimeter
  • Pressure: 168 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
46018
In Commercial Distribution

  • H965460181 ()
  • H965460180 ()
  • 15051684026932 ()

  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Length: 20 Centimeter
  • Needle Gauge: 21 Gauge


  • Peripheral intravenous cannula
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
46017
In Commercial Distribution

  • H965460171 ()
  • H965460170 ()
  • 15051684026918 ()

  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
  • Outer Diameter: 1.68 Millimeter
  • Catheter Gauge: 5 French


  • Peripheral intravenous cannula
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
46016
In Commercial Distribution

  • H965460161 ()
  • H965460160 ()
  • 15051684026895 ()

  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.4 Millimeter
  • Catheter Gauge: 4 French
  • Length: 20 Centimeter


  • Peripheral intravenous cannula
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
46015
In Commercial Distribution

  • H965460151 ()
  • H965460150 ()
  • 15051684026888 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 3 French
  • Length: 20 Centimeter
  • Outer Diameter: 1.02 Millimeter


  • Peripheral intravenous cannula
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