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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Pulse Generator DDDR
ST. JUDE MEDICAL, INC.
DR RF
In Commercial Distribution

  • H758PM221001 ()
  • 05414734503617 ()

  • Total Volume: 12.9 Milliliter
PM2210

  • Dual-chamber implantable pacemaker, rate-responsive
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
3107-30
Not in Commercial Distribution

  • H75831073006 ()
  • 05414734502214 ()

  • Total Volume: 37 Milliliter
3107-30

  • Cardiac resynchronization therapy implantable defibrillator
3mm Lead, 60 cm
ST. JUDE MEDICAL, INC.
3228
In Commercial Distribution

  • 05415067017253 ()

  • Outer Diameter: 3 Millimeter
  • Length: 60 Centimeter
3228

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Tiered-therapy cardioverter/defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
DR RF
Not in Commercial Distribution

  • H75822073006 ()
  • 05414734501910 ()

  • Total Volume: 38 Milliliter
2207-30

  • Dual-chamber implantable defibrillator
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVRO-35
In Commercial Distribution

  • 05415067045768 ()

  • Outer Diameter: 35.0000 Millimeter
NVRO-35

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Max Stented Tissue Valve
ST. JUDE MEDICAL, INC.
EMAX-25
In Commercial Distribution

  • 05415067045454 ()

  • Lumen/Inner Diameter: 26.3000 Millimeter
  • Height: 19.0000 Millimeter
EMAX-25

  • Aortic open-surgery heart valve bioprosthesis
Reprocessed ICE Catheter
ST. JUDE MEDICAL, INC.
D087031-R
In Commercial Distribution

  • 05415067041630 ()

  • Length: 90.0000 Centimeter
  • Catheter Gauge: 9.0000 French
D087031-R

  • Intracardiac ultrasound imaging catheter, steerable, reprocessed
ADAPTING SLEEVE KIT
ST. JUDE MEDICAL, INC.
4023
In Commercial Distribution

  • 05414734506441 ()

  • Length: 3.2 Millimeter
  • Length: 5 Millimeter
  • Outer Diameter: 6 Millimeter
4023

  • Pacing/defibrillation lead electrical adaptor
Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-034
In Commercial Distribution

  • 00811806011530 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 34.0000 Millimeter
9-SB-034

  • Cardiac sizing catheter
Pulse GeneratorSSIR
ST. JUDE MEDICAL, INC.
2525T
In Commercial Distribution

  • 05414734006224 ()

  • Total Volume: 5.9 Milliliter
2525T

  • Single-chamber implantable pacemaker, rate-responsive
No Description
ST. JUDE MEDICAL, INC.
406428
In Commercial Distribution

  • 15415067009460 ()
  • 05415067009463 ()

  • Length: 15 Centimeter
  • Catheter Gauge: 13 French
406428

  • Haemostasis valve obturator
Tiered-therapy cardioverter/defibrillatorVVEV VVIR
ST. JUDE MEDICAL, INC.
1107-36
In Commercial Distribution

  • 05414734502184 ()
  • H7581107360 ()

  • Total Volume: 38 Milliliter
1107-36

  • Single-chamber implantable defibrillator
Retrieval System
ST. JUDE MEDICAL, INC.
TENDV-RS2
In Commercial Distribution

  • 05415067046192 ()
TENDV-RS2

  • Mitral transcatheter heart valve bioprosthesis
Stand Components
ST. JUDE MEDICAL, INC.
TENDV-SC
In Commercial Distribution

  • 05415067032720 ()
TENDV-SC

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Pad Positioning System
ST. JUDE MEDICAL, INC.
TENDV-PS
In Commercial Distribution

  • 05415067032713 ()
TENDV-PS

  • Mitral transcatheter heart valve bioprosthesis
Loading System
ST. JUDE MEDICAL, INC.
TENDV-LS
In Commercial Distribution

  • 05415067032706 ()
TENDV-LS

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Delivery System
ST. JUDE MEDICAL, INC.
TENDV-DS
In Commercial Distribution

  • 05415067032690 ()
TENDV-DS

  • Mitral transcatheter heart valve bioprosthesis
Apical Pad - Large
ST. JUDE MEDICAL, INC.
TENDV-LPAD
In Commercial Distribution

  • 05415067032683 ()
TENDV-LPAD

  • Mitral transcatheter heart valve bioprosthesis
Apical Pad - Small
ST. JUDE MEDICAL, INC.
TENDV-SPAD
In Commercial Distribution

  • 05415067032676 ()
TENDV-SPAD

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-29L
In Commercial Distribution

  • 05415067032669 ()

  • Outer Diameter: 29.0000 Millimeter
TENDV-LP-29L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-29S
In Commercial Distribution

  • 05415067032652 ()

  • Outer Diameter: 29.0000 Millimeter
TENDV-LP-29S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-37M
In Commercial Distribution

  • 05415067032645 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-LP-37M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-37S
In Commercial Distribution

  • 05415067032638 ()
TENDV-LP-37S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-35M
In Commercial Distribution

  • 05415067032621 ()

  • Outer Diameter: 35.0000 Millimeter
TENDV-LP-35M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-35S
In Commercial Distribution

  • 05415067032614 ()
TENDV-LP-35S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-33M
In Commercial Distribution

  • 05415067032607 ()
TENDV-LP-33M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-33S
In Commercial Distribution

  • 05415067032591 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-LP-33S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37L
In Commercial Distribution

  • 05415067032584 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35L
In Commercial Distribution

  • 05415067032577 ()
TENDV-SP-35L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33L
In Commercial Distribution

  • 05415067032560 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-SP-33L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-41S
In Commercial Distribution

  • 05415067032553 ()
TENDV-SP-41S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-39M
In Commercial Distribution

  • 05415067032546 ()

  • Outer Diameter: 39.0000 Millimeter
TENDV-SP-39M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-39S
In Commercial Distribution

  • 05415067032539 ()
TENDV-SP-39S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37M
In Commercial Distribution

  • 05415067032522 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37S
In Commercial Distribution

  • 05415067032515 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35M
In Commercial Distribution

  • 05415067032508 ()

  • Outer Diameter: 35.0000 Millimeter
TENDV-SP-35M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35S
In Commercial Distribution

  • 05415067032492 ()
TENDV-SP-35S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33M
In Commercial Distribution

  • 05415067032485 ()
TENDV-SP-33M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33S
In Commercial Distribution

  • 05415067032478 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-SP-33S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33C
In Commercial Distribution

  • 05415067032461 ()
TENDV-SP-33C

  • Mitral transcatheter heart valve bioprosthesis
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