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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Ablation Catheter
ST. JUDE MEDICAL, INC.
A701157
In Commercial Distribution

  • 05415067011497 ()

  • Catheter Gauge: 8 French
A701157

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A701129
In Commercial Distribution

  • 05415067011152 ()

  • Catheter Gauge: 8 French
A701129

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A701128
In Commercial Distribution

  • 05415067011145 ()

  • Catheter Gauge: 8 French
A701128

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A701127
In Commercial Distribution

  • 05415067011138 ()

  • Catheter Gauge: 8 French
A701127

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A701125
In Commercial Distribution

  • 05415067011114 ()

  • Catheter Gauge: 8 French
A701125

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A701124
In Commercial Distribution

  • 05415067011107 ()

  • Catheter Gauge: 8 French
A701124

  • Cardiac radio-frequency ablation system catheter
ECG Cable
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067010995 ()
H701099

  • Cardiac mapping system
Cover Proximity Switch
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067010933 ()
H701093

  • Cardiac mapping system
System,230V
ST. JUDE MEDICAL, INC.
VS100006
In Commercial Distribution

  • 05415067010872 ()
VS100006

  • Image display unit, colour
System,120V
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05415067010865 ()
VS100005

  • Image display unit, colour
System,230V
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05415067010858 ()
VS100004

  • Image display unit, colour
System, 120V
ST. JUDE MEDICAL, INC.
VS100003
In Commercial Distribution

  • 05415067010841 ()
VS100003

  • Image display unit, colour
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
PRT-23
In Commercial Distribution

  • 05415067010728 ()

  • Outer Diameter: 23.0000 Millimeter
PRT-23

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Transducer Cable
ST. JUDE MEDICAL, INC.
C12688
In Commercial Distribution

  • 05415067010711 ()
C12688

  • Electrical-only medical device connection cable, reusable
Transducer Cable
ST. JUDE MEDICAL, INC.
C12687
In Commercial Distribution

  • 05415067010704 ()
C12687

  • Electrical-only medical device connection cable, reusable
Transducer Cable
ST. JUDE MEDICAL, INC.
C12686
In Commercial Distribution

  • 05415067010698 ()
C12686

  • Electrical-only medical device connection cable, reusable
Transducer Cable
ST. JUDE MEDICAL, INC.
C12685
In Commercial Distribution

  • 05415067010681 ()
C12685

  • Electrical-only medical device connection cable, reusable
Transducer Cable
ST. JUDE MEDICAL, INC.
C12684
In Commercial Distribution

  • 05415067010674 ()
C12684

  • Electrical-only medical device connection cable, reusable
No Description
ST. JUDE MEDICAL, INC.
405428
In Commercial Distribution

  • 15415067021042 ()
  • 05415067021045 ()

  • Catheter Gauge: 12 French
  • Length: 14 Centimeter
405428

  • Vascular catheter introduction set, nonimplantable
No Description
ST. JUDE MEDICAL, INC.
405422
In Commercial Distribution

  • 15415067021035 ()
  • 05415067021038 ()

  • Length: 14 Centimeter
  • Catheter Gauge: 10.5 French
405422

  • Vascular catheter introduction set, nonimplantable
No Description
ST. JUDE MEDICAL, INC.
405404
In Commercial Distribution

  • 15415067021011 ()
  • 05415067021014 ()

  • Catheter Gauge: 6 French
  • Length: 14 Centimeter
405404

  • Vascular catheter introduction set, nonimplantable
No Description
ST. JUDE MEDICAL, INC.
405270
In Commercial Distribution

  • 15415067021004 ()
  • 05415067021007 ()

  • Catheter Gauge: 8 French
  • Length: 23 Centimeter
405270

  • Vascular catheter introduction set, nonimplantable
No Description
ST. JUDE MEDICAL, INC.
405128
In Commercial Distribution

  • 15415067020960 ()
  • 05415067020963 ()

  • Length: 14 Centimeter
  • Catheter Gauge: 12 French
405128

  • Vascular catheter introduction set, nonimplantable
No Description
ST. JUDE MEDICAL, INC.
405124
In Commercial Distribution

  • 15415067020953 ()
  • 05415067020956 ()

  • Length: 14 Centimeter
  • Catheter Gauge: 11 French
405124

  • Vascular catheter introduction set, nonimplantable
No Description
ST. JUDE MEDICAL, INC.
405120
In Commercial Distribution

  • 15415067020939 ()
  • 05415067020932 ()

  • Length: 14 Centimeter
  • Catheter Gauge: 10 French
405120

  • Vascular catheter introduction set, nonimplantable
Printer
ST. JUDE MEDICAL, INC.
H701805
In Commercial Distribution

  • 05415067018052 ()
H701805

  • Ink printer
X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-03
In Commercial Distribution

  • 05415067053145 ()
ENSITE-D-FWV-03

  • Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-03
In Commercial Distribution

  • 05415067053138 ()
ENSITE-FWV-03

  • Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1.1
In Commercial Distribution

  • 05415067053121 ()
ENSITE-SW-3.1.1

  • Cardiac mapping system application software
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
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