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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DRG External Pulse Generator, 8 Channel
ST. JUDE MEDICAL, INC.
7599
In Commercial Distribution

  • 05415067027122 ()
7599

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
System
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067027085 ()
MG1000

  • Cardiac mapping system application software
Port Plug, DRG
ST. JUDE MEDICAL, INC.
7108
In Commercial Distribution

  • 15415067026993 ()
  • 05415067026996 ()
7108

  • Implantable pulse generator port plug
Lead & Extension Insertion Tool
ST. JUDE MEDICAL, INC.
1803
In Commercial Distribution

  • 15415067026696 ()
  • 05415067026699 ()
1803

  • Neurosurgical procedure kit, non-medicated, single-use
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-AVHDX-CBL
In Commercial Distribution

  • 05415067049667 ()

  • Length: 365.0000 Centimeter
D-ENS-AVHDX-CBL

  • Electrical-only medical device connection cable, reusable
HF Cardiac Resynchronization Therapy Defibrillator
ST. JUDE MEDICAL, INC.
CDHFA500T
In Commercial Distribution

  • 05415067049520 ()
CDHFA500T

  • Cardiac resynchronization therapy implantable defibrillator
DR Implantable Cardioverter Defibrillator
ST. JUDE MEDICAL, INC.
CDDRA300T
In Commercial Distribution

  • 05415067049469 ()
CDDRA300T

  • Dual-chamber implantable defibrillator
Catheter Interface Module
ST. JUDE MEDICAL, INC.
H701375-R
In Commercial Distribution

  • 05415067049285 ()
H701375-R

  • Electrical-only medical device connection cable, reusable
X Amplifier Air Filter
ST. JUDE MEDICAL, INC.
ENSITE-AAF-01
In Commercial Distribution

  • 05415067048721 ()
ENSITE-AAF-01

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

  • 05415067047168 ()
H800019

  • Cardiac catheterization monitoring system
Clinician Programmer
ST. JUDE MEDICAL, INC.
3874
In Commercial Distribution

3874

  • Multiple active implantable device programmer
Remote Control
ST. JUDE MEDICAL, INC.
H700490-CQM
In Commercial Distribution

  • 05415067046789 ()
H700490-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 EnSite Cloud Software License
ST. JUDE MEDICAL, INC.
ENSITE-CL-01
In Commercial Distribution

  • 05415067046697 ()
ENSITE-CL-01

  • Cardiac mapping system
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
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.
3670
In Commercial Distribution

  • 05415067046383 ()
3670

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
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-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
1.0 Software Update vF.0.1
ST. JUDE MEDICAL, INC.
1015191
In Commercial Distribution

  • 05415067045331 ()
1015191

  • Coronary optical coherence tomography system
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
33MECJ-502
In Commercial Distribution


  • Outer Diameter: 33.0000 Millimeter
33MECJ-502

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
31MECJ-502
In Commercial Distribution


  • Outer Diameter: 31.0000 Millimeter
31MECJ-502

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
29MECJ-502
In Commercial Distribution


  • Outer Diameter: 29.0000 Millimeter
29MECJ-502

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
27MECJ-502
In Commercial Distribution


  • Outer Diameter: 27.0000 Millimeter
27MECJ-502

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
25MECJ-502
In Commercial Distribution


  • Outer Diameter: 25.0000 Millimeter
25MECJ-502

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
23MECJ-502
In Commercial Distribution


  • Outer Diameter: 23.0000 Millimeter
23MECJ-502

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
21MECJ-502
In Commercial Distribution


  • Outer Diameter: 21.0000 Millimeter
21MECJ-502

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
19MECJ-502
In Commercial Distribution


  • Outer Diameter: 19.0000 Millimeter
19MECJ-502

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
37MJ-501
In Commercial Distribution


  • Outer Diameter: 37.0000 Millimeter
37MJ-501

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
35MJ-501
In Commercial Distribution


  • Outer Diameter: 35.0000 Millimeter
35MJ-501

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
33MJ-501
In Commercial Distribution


  • Outer Diameter: 33.0000 Millimeter
33MJ-501

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
31MJ-501
In Commercial Distribution


  • Outer Diameter: 31.0000 Millimeter
31MJ-501

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
29MJ-501
In Commercial Distribution


  • Outer Diameter: 29.0000 Millimeter
29MJ-501

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
27MJ-501
In Commercial Distribution


  • Outer Diameter: 27.0000 Millimeter
27MJ-501

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
25MJ-501
In Commercial Distribution


  • Outer Diameter: 25.0000 Millimeter
25MJ-501

  • Mitral bi-leaflet mechanical heart valve prosthesis
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