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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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WorkMate Claris™ - 05415067023209

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05415067023209 ()

  • Height: 8.5 Inch
  • Depth: 16.8 Inch
  • Width: 16.8 Inch
  • Weight: 33.4 Pound
H702320

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067020185

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05415067020185 ()
H702018

  • Cardiac catheterization monitoring system

MediGuide™ - 05415067018519

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MG1000
In Commercial Distribution

  • 05415067018519 ()
MG1000

  • Cardiac mapping system

EnSite™ - 05415067014856

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H701485
In Commercial Distribution

  • 05415067014856 ()
H701485

  • Cardiac mapping system

AVEIR™ - 05415067049971

Patient Transmitter Software
ST. JUDE MEDICAL, INC.
LSRM1000
In Commercial Distribution

  • 05415067049971 ()
LSRM1000

  • Transtelephonic implantable pacemaker analysis system

WorkMate Claris™ - 05415067047212

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800022
In Commercial Distribution

  • 05415067047212 ()
H800022

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067042385

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800014
In Commercial Distribution

  • 05415067042385 ()
H800014

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067042378

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800013
In Commercial Distribution

  • 05415067042378 ()
H800013

  • Cardiac catheterization monitoring system

WorkMate™ Scribe™ - 05415067042361

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800015
In Commercial Distribution

  • 05415067042361 ()
H800015

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067035615

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800012
In Commercial Distribution

  • 05415067035615 ()
H800012

  • Cardiac catheterization monitoring system

WorkMate™ Scribe™ - 05415067035592

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800008
In Commercial Distribution

  • 05415067035592 ()
H800008

  • Cardiac catheterization monitoring system

WorkMate™ Claris™ - 05415067035585

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800007
In Commercial Distribution

  • 05415067035585 ()
H800007

  • Cardiac catheterization monitoring system

EnSite Precision™ - 05415067033178

System Software Upgrade
ST. JUDE MEDICAL, INC.
H702602
In Commercial Distribution

  • 05415067033178 ()
H702602

  • Cardiac mapping system application software

AptiVue™ - 05415067030856

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
1014666
In Commercial Distribution

  • 05415067030856 ()
1014666

  • Coronary optical coherence tomography system

AptiVue™ - 05415067030108

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
1014661
In Commercial Distribution

  • 05415067030108 ()
1014661

  • Cardiac catheterization laboratory computer
  • Coronary optical coherence tomography system

QUANTIEN™ - 05415067030009

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution

  • 05415067030009 ()
H1014680

  • Cardiac catheterization laboratory computer

Quantien™ - 05415067029997

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution

  • 05415067029997 ()
H1014670

  • Cardiac catheterization laboratory computer

VNS Therapy™ Programmer, Model 3100 v1.1.0 - 05425025750634

Programmer and Software
LIVANOVA USA, INC.
3100
In Commercial Distribution

  • 05425025750634 ()


  • Vagus nerve electrical stimulation system programmer

AlignRT Plus - 05056190500818

AlignRT 6.2 software
VISION RT LIMITED
AlignRT 6.2
Not in Commercial Distribution

  • 05056190500818 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500689

AlignRT 6.3 software
VISION RT LIMITED
AlignRT 6.3
In Commercial Distribution

  • 05056190500689 ()


  • Radiological video camera patient positioning/tracking system
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