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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INTRODUCER,KIT 4FR X 11CM WITH .018X45CM SS/SS WIRE 21GX7CM NEEDLE
STRADIS MEDICAL, LLC
525-079
Not in Commercial Distribution

  • M7525250791 ()
  • M7525250793 ()
  • M7525250792 ()

  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge
  • Length: 11 Centimeter
525-079

  • Vascular catheter introduction set, nonimplantable
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM137544S
In Commercial Distribution

  • H965PKM137544S1 ()
  • PKM137544S0 ()

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


  • Peripherally-inserted central venous catheter
INTRODUCER ONE STEP 4FR X 45CM
STRADIS MEDICAL, LLC
525-029
Not in Commercial Distribution

  • M7525250292 ()
  • M7525250291 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French
525-029

  • Vascular catheter introduction set, nonimplantable
ONE STEP INTRODUCER KIT
STRADIS MEDICAL, LLC
525-028
Not in Commercial Distribution

  • M7525250282 ()
  • M7525250281 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French
525-028

  • Cardiac/peripheral vascular guidewire, single-use
INTRODUCER KIT, 4FRX20CM GW .018"X70CM MANDREL 21GX2.75 ECHO NEEDLE ONE STEP 10/BX
STRADIS MEDICAL, LLC
525-027
Not in Commercial Distribution

  • M7525250272 ()
  • M7525250271 ()

  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
525-027

  • Vascular catheter introduction set, nonimplantable
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61067723S
In Commercial Distribution

  • H965PKMR61067723S1 ()
  • H965PKMR61067723S0 ()

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


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61010891S
In Commercial Distribution

  • H965PKMR61010891S1 ()
  • H965PKMR61010891S0 ()

  • Catheter Gauge: 4 French
  • Single
  • Length: 45 Centimeter


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR22237S
In Commercial Distribution

  • H965PKMR22237S1 ()
  • H965PKMR22237S0 ()

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


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR215705S
In Commercial Distribution

  • H965PKMR215705S1 ()
  • H965PKMR215705S0 ()

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


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR215702S
In Commercial Distribution

  • H965PKMR215702S1 ()
  • H965PKMR215702S0 ()

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


  • Peripherally-inserted central venous catheter
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