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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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X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-04
In Commercial Distribution

  • 05415067051257 ()
ENSITE-DWS-04

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-04
In Commercial Distribution

  • 05415067051226 ()
ENSITE-R-DWS-04

  • Cardiac mapping system
CIWS WRLS MAS SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094231014 ()
  • 00732094118865 ()
85MXVX

  • Multiple vital physiological parameter monitoring system, clinical
CIWS STD MAS SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230901 ()
  • 00732094058086 ()
84MXVE

  • Multiple vital physiological parameter monitoring system, clinical
CIWS STD NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230888 ()
  • 00732094057485 ()
84NXVE

  • Multiple vital physiological parameter monitoring system, clinical
CIWS WRLS NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230857 ()
  • 00732094118803 ()
85NXVX

  • Multiple vital physiological parameter monitoring system, clinical
The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias.
Cortex, Inc.
FG0001-NA
In Commercial Distribution

  • 00850064686135 ()
OPTI-SYS-NA

  • Cardiac mapping system
OptiMap Monitor
Cortex, Inc.
FG0009
In Commercial Distribution

  • 00850064686029 ()
OPTI-MON

  • Cardiac mapping system
OptiMap Workstation
Cortex, Inc.
FG0008
In Commercial Distribution

  • 00850064686012 ()
OPTI-WS

  • Cardiac mapping system
CIWS STD NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230871 ()
  • 00732094119312 ()
84NXVX

  • Multiple vital physiological parameter monitoring system, clinical
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