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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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EnSite™ - 05415067046673

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-02
In Commercial Distribution

  • 05415067046673 ()
ENSITE-TFM-02

  • Cardiac mapping system application software

EnSite™ - 05415067046666

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-201
In Commercial Distribution

  • 05415067046666 ()
ENSITE-SYSTEM-201

  • Cardiac mapping system

EnSite™ - 05415067046659

X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution

  • 05415067046659 ()
ENSITE-TF-02

  • Cardiac mapping system application software

EnSite™ - 05415067046642

X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-01
In Commercial Distribution

  • 05415067046642 ()
ENSITE-OTAC-01

  • Cardiac mapping system application software

EnSite™ - 05415067046215

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.2
In Commercial Distribution

  • 05415067046215 ()
ENSITE-SW-1.1.2

  • Cardiac mapping system application software

EnSite Precision™ - 05415067046185

Software Upgrade
ST. JUDE MEDICAL, INC.
H704001
In Commercial Distribution

  • 05415067046185 ()
H704001

  • Cardiac mapping system application software

EnSite™ - 05415067042507

X EP System Advanced Mapping Software License
ST. JUDE MEDICAL, INC.
ENSITE-AM-2.0
In Commercial Distribution

  • 05415067042507 ()
ENSITE-AM-2.0

  • Cardiac mapping system application software

EnSite™ - 05415067042477

X EP System Advanced Mapping Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AM-2.0
In Commercial Distribution

  • 05415067042477 ()
ENSITE-D-AM-2.0

  • Cardiac mapping system application software

EnSite™ - 05415067042460

EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-2.0
In Commercial Distribution

  • 05415067042460 ()
ENSITE-SW-2.0

  • Cardiac mapping system application software

WorkMate Claris™ - 05415067042385

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

  • 05415067042385 ()
H800014

  • Cardiac catheterization monitoring system
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