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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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
X EP System EnSite Cloud Software License
ST. JUDE MEDICAL, INC.
ENSITE-CL-01
In Commercial Distribution

  • 05415067046697 ()
ENSITE-CL-01

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-2.0.1
In Commercial Distribution

  • 05415067046680 ()
ENSITE-R-DWS-2.0.1

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

  • 05415067046666 ()
ENSITE-SYSTEM-201

  • Cardiac mapping system
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
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
Helix Locking Tool
ST. JUDE MEDICAL, INC.
A001HELX
In Commercial Distribution

  • 05415067046512 ()
A001HELX

  • Torque manipulation device
Patient Transmitter
ST. JUDE MEDICAL, INC.
LSRM01
In Commercial Distribution

  • 05415067046475 ()
LSRM01

  • Transtelephonic implantable pacemaker analysis system
Patient Transmitter Wired Electrodes
ST. JUDE MEDICAL, INC.
LSRMC01
In Commercial Distribution

  • 05415067046468 ()
LSRMC01

  • Transtelephonic implantable pacemaker analysis system
Plus 7 Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3672
In Commercial Distribution

  • 05415067046406 ()
3672

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Plus 5 Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3671
In Commercial Distribution

  • 05415067046390 ()
3671

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Plus 5 Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3670
In Commercial Distribution

  • 05415067046383 ()
3670

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Plus 7 Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3673
In Commercial Distribution

  • 05415067046376 ()
3673

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Pacing Lead
ST. JUDE MEDICAL, INC.
LPA1231
In Commercial Distribution

  • 05415067046345 ()

  • Length: 46.0000 Centimeter
  • Catheter Gauge: 6.0000 French
LPA1231

  • Endocardial/interventricular septal pacing lead
Pacing Lead
ST. JUDE MEDICAL, INC.
LPA1231
In Commercial Distribution

  • 05415067046338 ()

  • Length: 58.0000 Centimeter
  • Catheter Gauge: 6.0000 French
LPA1231

  • Endocardial/interventricular septal pacing lead
Pacing Lead
ST. JUDE MEDICAL, INC.
LPA1231
In Commercial Distribution

  • 05415067046321 ()

  • Length: 65.0000 Centimeter
  • Catheter Gauge: 6.0000 French
LPA1231

  • Endocardial/interventricular septal pacing lead
Pacing Lead
ST. JUDE MEDICAL, INC.
LPA1231
In Commercial Distribution

  • 05415067046314 ()

  • Length: 52.0000 Centimeter
  • Catheter Gauge: 6.0000 French
LPA1231

  • Endocardial/interventricular septal pacing lead
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
Software Upgrade
ST. JUDE MEDICAL, INC.
H704001
In Commercial Distribution

  • 05415067046185 ()
H704001

  • Cardiac mapping system application software
Universal II Slitter
ST. JUDE MEDICAL, INC.
DS2A006
In Commercial Distribution

  • 05415067046178 ()
DS2A006

  • Intravascular catheter slitter
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVRO-23
In Commercial Distribution

  • 05415067045805 ()

  • Outer Diameter: 23.0000 Millimeter
NVRO-23

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVRO-27
In Commercial Distribution

  • 05415067045799 ()

  • Outer Diameter: 27.0000 Millimeter
NVRO-27

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVRO-25
In Commercial Distribution

  • 05415067045782 ()

  • Outer Diameter: 25.0000 Millimeter
NVRO-25

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVRO-29
In Commercial Distribution

  • 05415067045775 ()

  • Outer Diameter: 29.0000 Millimeter
NVRO-29

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Max Stented Tissue Valve
ST. JUDE MEDICAL, INC.
EMAX-23
In Commercial Distribution

  • 05415067045478 ()

  • Height: 17.0000 Millimeter
  • Lumen/Inner Diameter: 24.5000 Millimeter
EMAX-23

  • Aortic open-surgery heart valve bioprosthesis
Max Stented Tissue Valve
ST. JUDE MEDICAL, INC.
EMAX-19
In Commercial Distribution

  • 05415067045461 ()

  • Lumen/Inner Diameter: 20.8000 Millimeter
  • Height: 15.0000 Millimeter
EMAX-19

  • Aortic open-surgery heart valve bioprosthesis
Max Stented Tissue Valve
ST. JUDE MEDICAL, INC.
EMAX-21
In Commercial Distribution

  • 05415067045447 ()

  • Height: 16.0000 Millimeter
  • Lumen/Inner Diameter: 22.6000 Millimeter
EMAX-21

  • Aortic open-surgery heart valve bioprosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
31MTJ-503
In Commercial Distribution


  • Outer Diameter: 31.0000 Millimeter
31MTJ-503

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
29MTJ-503
In Commercial Distribution


  • Outer Diameter: 29.0000 Millimeter
29MTJ-503

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
27MTJ-503
In Commercial Distribution


  • Outer Diameter: 27.0000 Millimeter
27MTJ-503

  • Mitral bi-leaflet mechanical heart valve prosthesis
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