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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Insertable Cardiac Monitor
ST. JUDE MEDICAL, INC.
DM3500
In Commercial Distribution

  • 05415067027320 ()
DM3500

  • Implantable cardiac monitor
Circular Mapping Catheter
ST. JUDE MEDICAL, INC.
D-AVSE-DF20-V1525
In Commercial Distribution

  • 05415067027283 ()

  • Catheter Gauge: 8.0000 French
  • Length: 117.0000 Centimeter
D-AVSE-DF20-V1525

  • Cardiac mapping catheter, percutaneous, single-use
Circular Mapping Catheter
ST. JUDE MEDICAL, INC.
D-AVSE-DF10-V1525
In Commercial Distribution

  • 05415067027276 ()

  • Length: 117.0000 Centimeter
  • Catheter Gauge: 8.0000 French
D-AVSE-DF10-V1525

  • Cardiac mapping catheter, percutaneous, single-use
Circular Mapping Catheter
ST. JUDE MEDICAL, INC.
D-AVSE-D20-V1525
In Commercial Distribution

  • 05415067027269 ()

  • Catheter Gauge: 8.0000 French
  • Length: 117.0000 Centimeter
D-AVSE-D20-V1525

  • Cardiac mapping catheter, percutaneous, single-use
Circular Mapping Catheter
ST. JUDE MEDICAL, INC.
D-AVSE-D10-V1525
In Commercial Distribution

  • 05415067027252 ()

  • Catheter Gauge: 8.0000 French
  • Length: 117.0000 Centimeter
D-AVSE-D10-V1525

  • Cardiac mapping catheter, percutaneous, single-use
Connector Cable Kit
ST. JUDE MEDICAL, INC.
DRG
In Commercial Distribution

  • 05415067027238 ()
MN11350

  • Electrical-only medical device connection cable, single-use
Curved Needle
ST. JUDE MEDICAL, INC.
DRG
In Commercial Distribution

  • 05415067027221 ()

  • Length: 4.5000 Inch
  • Needle Gauge: 14.0000 Gauge
MN14000

  • Epidural needle, non-threaded
Lead Accessories Kit
ST. JUDE MEDICAL, INC.
DRG
In Commercial Distribution

  • 05415067027214 ()
MN12050

  • Neurosurgical procedure kit, non-medicated, single-use
Big Curve Delivery Sheath Kit
ST. JUDE MEDICAL, INC.
DRG
In Commercial Distribution

  • 05415067027207 ()

  • Length: 22.0000 Centimeter
MN13650

  • Neurosurgical procedure kit, non-medicated, single-use
Small Curve Delivery Sheath Kit
ST. JUDE MEDICAL, INC.
DRG
In Commercial Distribution

  • 05415067027191 ()

  • Length: 22.0000 Centimeter
MN12150

  • Neurosurgical procedure kit, non-medicated, single-use
Tunneling Tool Kit
ST. JUDE MEDICAL, INC.
DRG
In Commercial Distribution

  • 05415067027184 ()

  • Length: 30 Centimeter
MN15000

  • Neurosurgical procedure kit, non-medicated, single-use
Lead Extension Kit
ST. JUDE MEDICAL, INC.
DRG
In Commercial Distribution

  • 05415067027177 ()

  • Length: 50.0000 Centimeter
MN10550-50

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension
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
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