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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Catheter Interface Module
ST. JUDE MEDICAL, INC.
H701374-R
In Commercial Distribution

  • 05415067049278 ()
H701374-R

  • Electrical-only medical device connection cable, reusable
Steerable Delivery Sheath
ST. JUDE MEDICAL, INC.
STRBL-14F-075
In Commercial Distribution

  • 05415067049094 ()

  • Catheter Gauge: 14.0000 French
  • Length: 75.0000 Centimeter
STRBL-14F-075

  • Cardiac occluder delivery kit
X Amplifier Air Filter
ST. JUDE MEDICAL, INC.
ENSITE-AAF-01
In Commercial Distribution

  • 05415067048721 ()
ENSITE-AAF-01

  • Cardiac mapping system
Loading System - LG+
ST. JUDE MEDICAL, INC.
NVTR-LS-LG+
In Commercial Distribution

  • 05415067048417 ()
NVTR-LS-LG+

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
X EP System Averaged Impedance Drop Software License
ST. JUDE MEDICAL, INC.
ENSITE-IMP-01
In Commercial Distribution

  • 05415067048400 ()
ENSITE-IMP-01

  • Cardiac mapping system application software
X EP System EnSite VoXel Flex Mode Software License
ST. JUDE MEDICAL, INC.
ENSITE-FLEX-01
In Commercial Distribution

  • 05415067048394 ()
ENSITE-FLEX-01

  • Cardiac mapping system application software
X EP System LiveSync Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LS-01
In Commercial Distribution

  • 05415067048387 ()
ENSITE-D-LS-01

  • Cardiac mapping system application software
X EP System Averaged Impedance Drop Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-IMP-01
In Commercial Distribution

  • 05415067048370 ()
ENSITE-D-IMP-01

  • Cardiac mapping system application software
X EP System AutoMark Distance Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AMD-01
In Commercial Distribution

  • 05415067048363 ()
ENSITE-D-AMD-01

  • Cardiac mapping system application software
X EP System EnSite VoXel Flex Mode Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FLEX-01
In Commercial Distribution

  • 05415067048356 ()
ENSITE-D-FLEX-01

  • Cardiac mapping system application software
X EP System LiveSync Software License
ST. JUDE MEDICAL, INC.
ENSITE-LS-01
In Commercial Distribution

  • 05415067048349 ()
ENSITE-LS-01

  • Cardiac mapping system application software
X EP System AutoMark Distance Software License
ST. JUDE MEDICAL, INC.
ENSITE-AMD-01
In Commercial Distribution

  • 05415067048332 ()
ENSITE-AMD-01

  • Cardiac mapping system application software
Lead Kit
ST. JUDE MEDICAL, INC.
3189
In Commercial Distribution

  • 05415067047922 ()

  • Length: 90.0000 Centimeter
3189

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
X EP System TactiFlex Ablation Cath, SE Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-03
In Commercial Distribution

  • 05415067047861 ()
ENSITE-TFM-03

  • Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-03
In Commercial Distribution

  • 05415067047854 ()
ENSITE-SW-03

  • Cardiac mapping system application software
16 Lead
ST. JUDE MEDICAL, INC.
3292
In Commercial Distribution

  • 05415067047823 ()

  • Length: 60.0000 Centimeter
3292

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
3+ Insertable Cardiac Monitor
ST. JUDE MEDICAL, INC.
DM5300
In Commercial Distribution

  • 05415067047816 ()
DM5300

  • Implantable cardiac monitor
EL+ Insertable Cardiac Monitor
ST. JUDE MEDICAL, INC.
DM5500
In Commercial Distribution

  • 05415067047809 ()
DM5500

  • Implantable cardiac monitor
3 Insertable Cardiac Monitor
ST. JUDE MEDICAL, INC.
DM5000
In Commercial Distribution

  • 05415067047793 ()
DM5000

  • Implantable cardiac monitor
G4 Delivery System
ST. JUDE MEDICAL, INC.
TCDS0301-XTW
In Commercial Distribution

  • 05415067047755 ()

  • Length: 12.0000 Millimeter
  • Depth: 6.0000 Millimeter
  • Width: 22.0000 Millimeter
TCDS0301-XTW

  • Heart valve clip
Steerable Guide Catheter
ST. JUDE MEDICAL, INC.
TSGC0201
In Commercial Distribution

  • 05415067047748 ()

  • Outer Diameter: 8.4000 Millimeter
  • Length: 80.0000 Centimeter
TSGC0201

  • Vascular guide-catheter, single-use
G4 Delivery System
ST. JUDE MEDICAL, INC.
TCDS0301-XT
In Commercial Distribution

  • 05415067047731 ()

  • Width: 22.0000 Millimeter
  • Length: 12.0000 Millimeter
  • Depth: 4.0000 Millimeter
TCDS0301-XT

  • Heart valve clip
G4 Delivery System
ST. JUDE MEDICAL, INC.
TCDS0301-NTW
In Commercial Distribution

  • 05415067047724 ()

  • Depth: 6.0000 Millimeter
  • Length: 9.0000 Millimeter
  • Width: 17.0000 Millimeter
TCDS0301-NTW

  • Heart valve clip
G4 Delivery System
ST. JUDE MEDICAL, INC.
TCDS0301-NT
In Commercial Distribution

  • 05415067047700 ()

  • Length: 9.0000 Millimeter
  • Depth: 4.0000 Millimeter
  • Width: 17.0000 Millimeter
TCDS0301-NT

  • Heart valve clip
Merlin.net Software
ST. JUDE MEDICAL, INC.
MN7000
In Commercial Distribution

  • 05415067047311 ()
MN7000

  • Transtelephonic implantable pacemaker analysis system
Software Upgrade, 10 Licenses
ST. JUDE MEDICAL, INC.
H800020
In Commercial Distribution

  • 05415067047229 ()
H800020

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800022
In Commercial Distribution

  • 05415067047212 ()
H800022

  • Cardiac catheterization monitoring system
Module Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800018
In Commercial Distribution

  • 05415067047205 ()
H800018

  • Cardiac catheterization monitoring system
Software Upgrade Site License
ST. JUDE MEDICAL, INC.
H800021
In Commercial Distribution

  • 05415067047199 ()
H800021

  • Cardiac catheterization monitoring system
Z620 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800016
In Commercial Distribution

  • 05415067047182 ()
H800016

  • Cardiac catheterization monitoring system
Z440 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800017
In Commercial Distribution

  • 05415067047175 ()
H800017

  • Cardiac catheterization monitoring system
Module Software Upgrade Single License
ST. JUDE MEDICAL, INC.
H800019
In Commercial Distribution

  • 05415067047168 ()
H800019

  • Cardiac catheterization monitoring system
Patient Controller
ST. JUDE MEDICAL, INC.
3875
In Commercial Distribution

3875

  • Multiple active implantable device programmer
Clinician Programmer
ST. JUDE MEDICAL, INC.
3874
In Commercial Distribution

3874

  • Multiple active implantable device programmer
Software Upgrade
ST. JUDE MEDICAL, INC.
H704002
In Commercial Distribution

  • 05415067046802 ()
H704002

  • Cardiac mapping system application software
Remote Control
ST. JUDE MEDICAL, INC.
H700490-CQM
In Commercial Distribution

  • 05415067046789 ()
H700490-CQM

  • Cardiac radio-frequency ablation system generator
Generator Kit
ST. JUDE MEDICAL, INC.
H700494-CQM
In Commercial Distribution

  • 05415067046741 ()
H700494-CQM

  • Cardiac radio-frequency ablation system generator
Generator
ST. JUDE MEDICAL, INC.
H700488-CQM
In Commercial Distribution

  • 05415067046734 ()
H700488-CQM

  • Cardiac radio-frequency ablation system generator
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-2.0.1
In Commercial Distribution

  • 05415067046710 ()
ENSITE-DWS-2.0.1

  • Cardiac mapping system
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-2.0.1
In Commercial Distribution

  • 05415067046703 ()
ENSITE-SW-2.0.1

  • Cardiac mapping system application software
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