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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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Merlin™ - 05414734509725

PCS 3330 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
3330
In Commercial Distribution

  • 05414734509725 ()
3330

  • Implantable cardiac device management application software

EnSite™ - 05415067001856

Software Upgrade Kit v.3.1
ST. JUDE MEDICAL, INC.
H700185
In Commercial Distribution

  • 05415067001856 ()
H700185

  • Cardiac mapping system application software

EP-WorkMate™ - 05415067000866

Software Upgrade Kit v.4.3.2
ST. JUDE MEDICAL, INC.
H700086
In Commercial Distribution

  • 05415067000866 ()
H700086

  • Cardiac catheterization monitoring system

EnSite™ - 05415067053121

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1.1
In Commercial Distribution

  • 05415067053121 ()
ENSITE-SW-3.1.1

  • Cardiac mapping system application software

EnSite™ - 05415067050014

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.0.2
In Commercial Distribution

  • 05415067050014 ()
ENSITE-SW-3.0.2

  • Cardiac mapping system application software

EnSite™ - 05415067049704

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1
In Commercial Distribution

  • 05415067049704 ()
ENSITE-SW-3.1

  • Cardiac mapping system application software

STarFix™ Designer - 00873263008607

STarFix™ Designer Software, Version
FHC, INC.
C0265-00860
In Commercial Distribution

  • 00873263008607 ()
C0265

  • Stereotactic neuronavigation/planning system

Cycler Control v2.2 - 00858637005871

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005871 ()


  • Laboratory instrument/analyser application software IVD

STARlet Interface v2.2 - 00858637005864

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005864 ()


  • Laboratory instrument/analyser application software IVD

Analysis Client v2.2 - 00858637005857

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005857 ()


  • Laboratory instrument/analyser application software IVD
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