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 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
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
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