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 Catheter Connector Cable
ST. JUDE MEDICAL, INC.
ICE-VFSE-2D-CBL
In Commercial Distribution

  • 05415067051875 ()
ICE-VFSE-2D-CBL

  • Electrical-only medical device connection cable, reusable
Steerable Introducer
ST. JUDE MEDICAL, INC.
SI-1371-M
In Commercial Distribution

  • 05415067051851 ()

  • Length: 71.0000 Centimeter
  • Catheter Gauge: 13.0000 French
SI-1371-M

  • Vascular guide-catheter, single-use
Steerable Introducer
ST. JUDE MEDICAL, INC.
SI-1371-L
In Commercial Distribution

  • 05415067051844 ()

  • Catheter Gauge: 13.0000 French
  • Length: 71.0000 Centimeter
SI-1371-L

  • Vascular guide-catheter, single-use
Slitter
ST. JUDE MEDICAL, INC.
DS4A001
In Commercial Distribution

  • 05415067051325 ()

  • Catheter Gauge: 7.3000 French
DS4A001

  • Intravascular catheter slitter
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-3.1
In Commercial Distribution

  • 05415067051165 ()
ENSITE-SYSTEM-3.1

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-3.1
In Commercial Distribution

  • 05415067051141 ()
ENSITE-R-DWS-3.1

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-3.1
In Commercial Distribution

  • 05415067051134 ()
ENSITE-R-SYS-3.1

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-3.1
In Commercial Distribution

  • 05415067051127 ()
ENSITE-DWS-3.1

  • Cardiac mapping system
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-02
In Commercial Distribution

  • 05415067051110 ()
ENSITE-FWV-02

  • Cardiac mapping system application software
X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled Software License
ST. JUDE MEDICAL, INC.
ENSITE-HDGX-01
In Commercial Distribution

  • 05415067051103 ()
ENSITE-HDGX-01

  • Cardiac mapping system application software
X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-02
In Commercial Distribution

  • 05415067051097 ()
ENSITE-D-FWV-02

  • Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-01
In Commercial Distribution

  • 05415067050298 ()
ENSITE-FWV-01

  • Cardiac mapping system application software
X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-01
In Commercial Distribution

  • 05415067050281 ()
ENSITE-D-FWV-01

  • Cardiac mapping system application software
Steerable Introducer
ST. JUDE MEDICAL, INC.
SI-1371-S
In Commercial Distribution

  • 05415067050182 ()

  • Catheter Gauge: 13.0000 French
  • Length: 71.0000 Centimeter
SI-1371-S

  • Vascular guide-catheter, single-use
HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA300D
In Commercial Distribution

  • 05415067050120 ()
CDHFA300D

  • Cardiac resynchronization therapy implantable defibrillator
HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA300B
In Commercial Distribution

  • 05415067050106 ()
CDHFA300B

  • Cardiac resynchronization therapy implantable defibrillator
HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA500B
In Commercial Distribution

  • 05415067050090 ()
CDHFA500B

  • Cardiac resynchronization therapy implantable defibrillator
NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA600B
In Commercial Distribution

  • 05415067050076 ()
CDHFA600B

  • Cardiac resynchronization therapy implantable defibrillator
HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA500D
In Commercial Distribution

  • 05415067050052 ()
CDHFA500D

  • Cardiac resynchronization therapy implantable defibrillator
NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA600D
In Commercial Distribution

  • 05415067050045 ()
CDHFA600D

  • Cardiac resynchronization therapy implantable defibrillator
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.0.2
In Commercial Distribution

  • 05415067050021 ()
ENSITE-TFM-3.0.2

  • Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.0.2
In Commercial Distribution

  • 05415067050014 ()
ENSITE-SW-3.0.2

  • Cardiac mapping system application software
X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-02
In Commercial Distribution

  • 05415067049988 ()
ENSITE-OTAC-02

  • Cardiac mapping system application software
Patient Transmitter Software
ST. JUDE MEDICAL, INC.
LSRM1000
In Commercial Distribution

  • 05415067049971 ()
LSRM1000

  • Transtelephonic implantable pacemaker analysis system
High Density Mapping Catheter
ST. JUDE MEDICAL, INC.
D-AVHDX-DF16
In Commercial Distribution

  • 05415067049889 ()

  • Length: 110.0000 Centimeter
  • Catheter Gauge: 8.0000 French
D-AVHDX-DF16

  • Cardiac mapping catheter, percutaneous, single-use
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.1
In Commercial Distribution

  • 05415067049711 ()
ENSITE-TFM-3.1

  • Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1
In Commercial Distribution

  • 05415067049704 ()
ENSITE-SW-3.1

  • Cardiac mapping system application software
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
Grounding Pad
ST. JUDE MEDICAL, INC.
RF-DGP-IZ
In Commercial Distribution

  • 05415067049650 ()
  • 15415067049657 ()
RF-DGP-IZ

  • Electrosurgical return electrode, single-use
Live Connect Remote Session Engine
ST. JUDE MEDICAL, INC.
MLC1000
In Commercial Distribution

  • 05415067049575 ()
MLC1000

  • Implantable cardiac device management application software
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
9-ACP2-010-034
In Commercial Distribution

  • 00811806013527 ()

  • Outer Diameter: 34.0000 Millimeter
9-ACP2-010-034

  • Cardiac defect occluder
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
9-ACP2-010-031
In Commercial Distribution

  • 00811806013510 ()

  • Outer Diameter: 31.0000 Millimeter
9-ACP2-010-031

  • Cardiac defect occluder
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
9-ACP2-010-028
In Commercial Distribution

  • 00811806013503 ()

  • Outer Diameter: 28.0000 Millimeter
9-ACP2-010-028

  • Cardiac defect occluder
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
9-ACP2-010-025
In Commercial Distribution

  • 00811806013497 ()

  • Outer Diameter: 25.0000 Millimeter
9-ACP2-010-025

  • Cardiac defect occluder
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
9-ACP2-007-022
In Commercial Distribution

  • 00811806013480 ()

  • Outer Diameter: 22.0000 Millimeter
9-ACP2-007-022

  • Cardiac defect occluder
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
9-ACP2-007-020
In Commercial Distribution

  • 00811806013473 ()

  • Outer Diameter: 20.0000 Millimeter
9-ACP2-007-020

  • Cardiac defect occluder
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
9-ACP2-007-018
In Commercial Distribution

  • 00811806013466 ()

  • Outer Diameter: 18.0000 Millimeter
9-ACP2-007-018

  • Cardiac defect occluder
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
9-ACP2-007-016
In Commercial Distribution

  • 00811806013459 ()

  • Outer Diameter: 16.0000 Millimeter
9-ACP2-007-016

  • Cardiac defect occluder
LP Catheter
ST. JUDE MEDICAL, INC.
9-TVLPC4F90/080
In Commercial Distribution

  • 00811806012926 ()

  • Catheter Gauge: 4 French
  • Length: 80 Centimeter
9-TVLPC4F90/080

  • Cardiac occluder delivery kit
2 Delivery Sheath
ST. JUDE MEDICAL, INC.
9-TV2-07F120
In Commercial Distribution

  • 00811806012551 ()

  • Catheter Gauge: 7 French
9-TV2-07F120

  • Cardiac occluder delivery kit
2 Delivery Sheath
ST. JUDE MEDICAL, INC.
9-TV2-06F120
In Commercial Distribution

  • 00811806012513 ()

  • Catheter Gauge: 6 French
9-TV2-06F120

  • Cardiac occluder delivery kit
2 Delivery Sheath
ST. JUDE MEDICAL, INC.
9-TV2-05F120
In Commercial Distribution

  • 00811806012476 ()

  • Catheter Gauge: 5 French
9-TV2-05F120

  • Cardiac occluder delivery kit
LP Delivery System
ST. JUDE MEDICAL, INC.
9-TVLP5F90/080
In Commercial Distribution

  • 00811806011592 ()

  • Catheter Gauge: 5 French
  • Length: 80.0000 Centimeter
9-TVLP5F90/080

  • Cardiac occluder delivery kit
LP Delivery System
ST. JUDE MEDICAL, INC.
9-TVLP4F90/080
In Commercial Distribution

  • 00811806011578 ()

  • Catheter Gauge: 4 French
  • Length: 80.0000 Centimeter
9-TVLP4F90/080

  • Cardiac occluder delivery kit
Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-018
In Commercial Distribution

  • 00811806011516 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 18.0000 Millimeter
9-SB-018

  • Cardiac sizing catheter
Duct Occluder II
ST. JUDE MEDICAL, INC.
9-PDA2-03-06
In Commercial Distribution

  • 00811806011189 ()

  • Outer Diameter: 3 Millimeter
9-PDA2-03-06

  • Cardiac defect occluder
Duct Occluder
ST. JUDE MEDICAL, INC.
9-PDA-007
In Commercial Distribution

  • 00811806011141 ()

  • Outer Diameter: 12 Millimeter
9-PDA-007

  • Cardiac defect occluder
Multifenestrated Septal Occluder Cribriform
ST. JUDE MEDICAL, INC.
9-ASD-MF-035
In Commercial Distribution

  • 00811806010311 ()

  • Outer Diameter: 35 Millimeter
9-ASD-MF-035

  • Cardiac defect occluder
Multifenestrated Septal Occluder Cribriform
ST. JUDE MEDICAL, INC.
9-ASD-MF-030
In Commercial Distribution

  • 00811806010304 ()

  • Outer Diameter: 30 Millimeter
9-ASD-MF-030

  • Cardiac defect occluder
Multifenestrated Septal Occluder Cribriform
ST. JUDE MEDICAL, INC.
9-ASD-MF-025
In Commercial Distribution

  • 00811806010298 ()

  • Outer Diameter: 25 Millimeter
9-ASD-MF-025

  • Cardiac defect occluder
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