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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™ Courier™ - 05415067026170

Software Installation, v.3.0
ST. JUDE MEDICAL, INC.
H702501
In Commercial Distribution

  • 05415067026170 ()
H702501

  • Cardiac mapping system application software

EnSite™ - 05415067026163

Module, 30 day trial, v.1.0
ST. JUDE MEDICAL, INC.
AutoMap
In Commercial Distribution

  • 05415067026163 ()
H702498-T

  • Cardiac mapping system application software

AutoMark - 05415067026149

Software Installation, v.1.0
ST. JUDE MEDICAL, INC.
H702499
In Commercial Distribution

  • 05415067026149 ()
H702499

  • Cardiac mapping system application software

EnSite™ - 05415067026132

Module, v.1.0
ST. JUDE MEDICAL, INC.
AutoMap
In Commercial Distribution

  • 05415067026132 ()
H702498

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026125

Software Installation, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496
In Commercial Distribution

  • 05415067026125 ()
H702496

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026118

Software Installation, 30 day trial, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496-T
In Commercial Distribution

  • 05415067026118 ()
H702496-T

  • Cardiac mapping system application software

EnSite™ Velocity™ - 05415067026101

Software Upgrade Kit, v.5.0.2
ST. JUDE MEDICAL, INC.
H702495
In Commercial Distribution

  • 05415067026101 ()
H702495

  • Cardiac mapping system application software

EnSite Precision™ - 05415067025937

Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0020-P
In Commercial Distribution

  • 05415067025937 ()
EN0020-P

  • Cardiac mapping system reference patch

EnSite Precision™ - 05415067025265

Patient Reference Sensor
ST. JUDE MEDICAL, INC.
H702492
In Commercial Distribution

  • 05415067025265 ()
H702492

  • Patient positioning sensor

EnSite™ - 05415067024909

Noise Reduction Transformer, 100V
ST. JUDE MEDICAL, INC.
H702490
In Commercial Distribution

  • 05415067024909 ()
H702490

  • Constant-voltage transformer
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