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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Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405116
In Commercial Distribution

  • 15415067040913 ()
  • 05415067040916 ()
  • 05414734204149 ()

  • Catheter Gauge: 9.0000 French
  • Length: 14.0000 Centimeter
405116

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405112
In Commercial Distribution

  • 15415067040890 ()
  • 05415067040893 ()
  • 05414734204125 ()

  • Catheter Gauge: 8.0000 French
  • Length: 14.0000 Centimeter
405112

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405108
In Commercial Distribution

  • 15415067040876 ()
  • 05415067040879 ()
  • 05414734204101 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 7.0000 French
405108

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405104
In Commercial Distribution

  • 15415067040852 ()
  • 05415067040855 ()
  • 05414734204088 ()

  • Catheter Gauge: 6.0000 French
  • Length: 14.0000 Centimeter
405104

  • Vascular catheter introduction set, nonimplantable
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.1
In Commercial Distribution

  • 05415067040770 ()
ENSITE-SW-1.1.1

  • Cardiac mapping system application software
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
32400
In Commercial Distribution

  • 05415067040763 ()
32400

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP202V
In Commercial Distribution

  • 05415067040725 ()
LSP202V

  • Intracardiac pacemaker
Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP201A
In Commercial Distribution

  • 05415067040701 ()
LSP201A

  • Intracardiac pacemaker
MerlinAtHome Software
ST. JUDE MEDICAL, INC.
EX2000
In Commercial Distribution

  • 05415067040404 ()
EX2000

  • Transtelephonic implantable pacemaker analysis system
Insertable Cardiac Monitor
ST. JUDE MEDICAL, INC.
DM4500
In Commercial Distribution

  • 05415067040046 ()
DM4500

  • Implantable cardiac monitor
Delivery Catheter
ST. JUDE MEDICAL, INC.
LSCD201
In Commercial Distribution

  • 05415067038487 ()
LSCD201

  • Vascular guide-catheter, single-use
X EP System Wave Speed Map Software License
ST. JUDE MEDICAL, INC.
ENSITE-WS-01
In Commercial Distribution

  • 05415067038111 ()
ENSITE-WS-01

  • Cardiac mapping system application software
Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution

  • 05415067037770 ()
ENSITE-OTEXPORT-01

  • Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-1.1
In Commercial Distribution

  • 05415067037756 ()
ENSITE-R-DWS-1.1

  • Cardiac mapping system
X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution

  • 05415067037749 ()
ENSITE-D-LV-01

  • Cardiac mapping system application software
X EP System Live Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-LE-01
In Commercial Distribution

  • 05415067037732 ()
ENSITE-LE-01

  • Cardiac mapping system application software
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-1.1
In Commercial Distribution

  • 05415067037725 ()
ENSITE-DWS-1.1

  • Cardiac mapping system
X EP System LiveView Dynamic Display Software License
ST. JUDE MEDICAL, INC.
ENSITE-LV-01
In Commercial Distribution

  • 05415067037718 ()
ENSITE-LV-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Software License
ST. JUDE MEDICAL, INC.
ENSITE-OT-01
In Commercial Distribution

  • 05415067037701 ()
ENSITE-OT-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-OT-01
In Commercial Distribution

  • 05415067037695 ()
ENSITE-D-OT-01

  • Cardiac mapping system application software
Monitor Cable
ST. JUDE MEDICAL, INC.
C12849
In Commercial Distribution

  • 05415067037572 ()
C12849

  • Electrical-only medical device connection cable, reusable
Imaging System
ST. JUDE MEDICAL, INC.
1014932
In Commercial Distribution

  • 05415067037558 ()
1014932

  • Coronary optical coherence tomography system
G4 Clip Delivery System
ST. JUDE MEDICAL, INC.
CDS0706-NTW
In Commercial Distribution

  • 05415067037435 ()

  • Depth: 6.0000 Millimeter
  • Width: 17.0000 Millimeter
  • Length: 9.0000 Millimeter
CDS0706-NTW

  • Heart valve clip
G4 Clip Delivery System
ST. JUDE MEDICAL, INC.
CDS0706-XT
In Commercial Distribution

  • 05415067037404 ()

  • Depth: 4.0000 Millimeter
  • Width: 22.0000 Millimeter
  • Length: 12.0000 Millimeter
CDS0706-XT

  • Heart valve clip
G4 Clip Delivery System
ST. JUDE MEDICAL, INC.
CDS0706-XTW
In Commercial Distribution

  • 05415067037381 ()

  • Width: 22.0000 Millimeter
  • Depth: 6.0000 Millimeter
  • Length: 12.0000 Millimeter
CDS0706-XTW

  • Heart valve clip
G4 Clip Delivery System
ST. JUDE MEDICAL, INC.
CDS0706-NT
In Commercial Distribution

  • 05415067037367 ()

  • Depth: 4.0000 Millimeter
  • Width: 17.0000 Millimeter
  • Length: 9.0000 Millimeter
CDS0706-NT

  • Heart valve clip
Suture Sleeve
ST. JUDE MEDICAL, INC.
DS2A088
In Commercial Distribution

  • 05415067037275 ()

  • Catheter Gauge: 6.0000 French
DS2A088

  • Implantable electrical stimulation lead suture sleeve
Integrated Pre-Installation Kit
ST. JUDE MEDICAL, INC.
1014943
In Commercial Distribution

  • 05415067037268 ()
1014943

  • Coronary optical coherence tomography system
Mobile Next Connectivity Box FRU
ST. JUDE MEDICAL, INC.
1014945
In Commercial Distribution

  • 05415067037183 ()
1014945

  • Coronary optical coherence tomography system
Mobile Installation Kit
ST. JUDE MEDICAL, INC.
1014944
In Commercial Distribution

  • 05415067037169 ()
1014944

  • Coronary optical coherence tomography system
Integrated Next Imaging System
ST. JUDE MEDICAL, INC.
1014933
In Commercial Distribution

  • 05415067037145 ()
1014933

  • Coronary optical coherence tomography system
2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software
Integrated Next Upgrade Kit
ST. JUDE MEDICAL, INC.
1014935
In Commercial Distribution

  • 05415067036858 ()
1014935

  • Coronary optical coherence tomography system
Next Doc Holster FRU
ST. JUDE MEDICAL, INC.
1014941
In Commercial Distribution

  • 05415067036810 ()
1014941

  • Coronary optical coherence tomography system
Mobile Next Upgrade Kit
ST. JUDE MEDICAL, INC.
1014934
In Commercial Distribution

  • 05415067036742 ()
1014934

  • Coronary optical coherence tomography system
OPTISi Next Monitor
ST. JUDE MEDICAL, INC.
1014942
In Commercial Distribution

  • 05415067036728 ()
1014942

  • Coronary optical coherence tomography system
OPTISi Next DOC
ST. JUDE MEDICAL, INC.
1014940
In Commercial Distribution

  • 05415067036704 ()
1014940

  • Coronary optical coherence tomography system
OPTISm Next DOC
ST. JUDE MEDICAL, INC.
1014939
In Commercial Distribution

  • 05415067036681 ()
1014939

  • Coronary optical coherence tomography system
Loading System
ST. JUDE MEDICAL, INC.
NVTR-LS-SM
In Commercial Distribution

  • 05415067036667 ()
NVTR-LS-SM

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Loading System
ST. JUDE MEDICAL, INC.
NVTR-LS-LG
In Commercial Distribution

  • 05415067036650 ()
NVTR-LS-LG

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Integrated Next
ST. JUDE MEDICAL, INC.
1014938
In Commercial Distribution

  • 05415067036643 ()
1014938

  • Coronary optical coherence tomography system
Mobile Next
ST. JUDE MEDICAL, INC.
1014937
In Commercial Distribution

  • 05415067036629 ()
1014937

  • Coronary optical coherence tomography system
PRE-CONNECTED PACK
ST. JUDE MEDICAL, INC.
CMAEK00
In Commercial Distribution

  • 05415067036414 ()
CMAEK00

  • Cardiopulmonary bypass system priming set
  • Cardiopulmonary bypass system centrifugal pump
Delivery Catheter
ST. JUDE MEDICAL, INC.
LSCD111
In Commercial Distribution

  • 05415067036384 ()

  • Outer Diameter: 6.8000 Millimeter
  • Length: 105.0000 Centimeter
LSCD111

  • Vascular guide-catheter, single-use
Steerable Delivery Sheath
ST. JUDE MEDICAL, INC.
ASDS-14F-075
Not in Commercial Distribution

  • 05415067036025 ()

  • Length: 75.0000 Centimeter
ASDS-14F-075

  • Cardiac occluder delivery kit
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800012
In Commercial Distribution

  • 05415067035615 ()
H800012

  • Cardiac catheterization monitoring system
Software Installation
ST. JUDE MEDICAL, INC.
H800009
In Commercial Distribution

  • 05415067035608 ()
H800009

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800008
In Commercial Distribution

  • 05415067035592 ()
H800008

  • Cardiac catheterization monitoring system
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