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

  • 05415067042378 ()
H800013

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800015
In Commercial Distribution

  • 05415067042361 ()
H800015

  • Cardiac catheterization monitoring system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-111
In Commercial Distribution

  • 05415067041722 ()
ENSITE-SYSTEM-111

  • Cardiac mapping system
Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0020-P
In Commercial Distribution

  • 15415067041712 ()
  • 05415067041715 ()
EN0020-P

  • Cardiac mapping system reference patch
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.1
In Commercial Distribution

  • 05415067040770 ()
ENSITE-SW-1.1.1

  • Cardiac mapping system application software
X EP System Wave Speed Map Software License
ST. JUDE MEDICAL, INC.
ENSITE-WS-01
In Commercial Distribution

  • 05415067038111 ()
ENSITE-WS-01

  • Cardiac mapping system application software
Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution

  • 05415067037770 ()
ENSITE-OTEXPORT-01

  • Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-1.1
In Commercial Distribution

  • 05415067037756 ()
ENSITE-R-DWS-1.1

  • Cardiac mapping system
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