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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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WA Holter System - 90815187020290

HR300 Mini Holter Recorder Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020290 ()
404955

  • Electrocardiographic ambulatory recorder

Scanner S300 - D800ERAB4061

Scanner S300 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4061
In Commercial Distribution

  • D800ERAB4061 ()


  • Dental milling system, CAD/CAM, laboratory

Scanner S900 - D800ERAB4051

Scanner S900 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4051
In Commercial Distribution

  • D800ERAB4051 ()


  • Dental milling system, CAD/CAM, laboratory

Surgical Direct - B382SD101790

11mm Trocar Screw Shaft for Exchange
Surgical Direct, Inc.
SD10179
In Commercial Distribution

  • B382SD101790 ()

  • Outer Diameter: 11 Millimeter
SD10179

  • Endoscope sheath, reusable

TranS1 - 00815361020297

AxiaLIF Plus Exchange System Fixation Wire
QUANDARY MEDICAL LLC
TR1-2212
In Commercial Distribution

  • 00815361020297 ()


  • Orthopaedic bone wire

VYGON - 03660812009386

4 way stopcock for exchange transfusion
VYGON
879.00
In Commercial Distribution

  • 33660812009387 ()
  • 03660812009386 ()
  • 53660812009381 ()
879.00

  • Intravenous line stopcock

RapidCross - 00821684051115

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040210170
In Commercial Distribution

  • 00821684051115 ()

  • Length: 210 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,CM;Compatible Guidewire,0.014,IN;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;Diameter,4-3.5,MM


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051108

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040150170
In Commercial Distribution

  • 00821684051108 ()

  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Length: 150 Millimeter
  • Outer Diameter: 4 Millimeter


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051092

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040120170
In Commercial Distribution

  • 00821684051092 ()

  • Length: 120 Millimeter
  • Outer Diameter: 4 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684051085

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040100170
In Commercial Distribution

  • 00821684051085 ()

  • Length: 100 Millimeter
  • Outer Diameter: 4 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic
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