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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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Alto™ Abdominal Stent Graft System - 00850007370381

"The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2."
Endologix, Inc.
TV-AB2080-N
In Commercial Distribution

  • 00850007370381 ()

  • Stent Diameter: 20 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 80 Millimeter
TV-AB2080-N

  • Abdominal aorta endovascular stent-graft

SJM MRI Activator™ - 05414734503648

Handheld Device
ST. JUDE MEDICAL, INC.
EX4000
In Commercial Distribution

  • 05414734503648 ()
EX4000

  • Multiple active implantable device programmer

SenoClaire - 00840682100076

SenoClaire LLH2
GE MEDICAL SYSTEMS
LLH2
Not in Commercial Distribution

  • 00840682100076 ()
5434135-5

  • Stationary mammographic x-ray system, digital

SenoClaire - 00840682100045

Digital Breast Tomosynthesis option for Senographe Essential
GE MEDICAL SYSTEMS
LLH1
Not in Commercial Distribution

  • 00840682100045 ()
5434135-4

  • Stationary mammographic x-ray system, digital

MiniMed® 530G - 00643169507272

PUMP MMT-551PNAH PRDGM V3.0 PK US PW
MEDTRONIC MINIMED, INC.
MMT-551PNAH
In Commercial Distribution

  • 00643169507272 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm

Promote Accel™ - 05414734503099

Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CD3215-36Q
Not in Commercial Distribution

  • 05414734503099 ()

  • Total Volume: 42 Milliliter
CD3215-36Q

  • Cardiac resynchronization therapy implantable defibrillator

Current Accel® - 05414734503075

Tiered-therapy cardioverter/defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
DR
Not in Commercial Distribution

  • 05414734503075 ()
  • H758CD221536Q0 ()

  • Total Volume: 41 Milliliter
CD2215-36Q

  • Dual-chamber implantable defibrillator

Current Accel™ - 05414734503044

Tiered-therapy cardioverter/defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
VR
Not in Commercial Distribution

  • 05414734503044 ()

  • Total Volume: 41 Milliliter
CD1215-36Q

  • Single-chamber implantable defibrillator

Promote® - 05414734502252

Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
RF
Not in Commercial Distribution

  • H75832073007 ()
  • 05414734502252 ()

  • Total Volume: 39 Milliliter
3207-30

  • Cardiac resynchronization therapy implantable defibrillator

Current® - 05414734502207

Tiered-therapy cardioverter/defibrillatorVVED DDDR
ST. JUDE MEDICAL, INC.
2107-36
In Commercial Distribution

  • 05414734502207 ()
  • H7582107360 ()

  • Total Volume: 39 Milliliter
2107-36

  • Dual-chamber implantable defibrillator
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