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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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Mi1000 MED-EL CONCERT +FLEX28 - 09008737083632

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08363
Not in Commercial Distribution

  • 09008737083632 ()
08842

  • Cochlear implant system electrode array assembly

Mi1000 MED-EL CONCERT PIN +FLEX28 - 09008737083625

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08362
Not in Commercial Distribution

  • 09008737083625 ()
08841

  • Cochlear implant system electrode array assembly

SONATATI100 +FLEX28 - 09008737083618

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08361
Not in Commercial Distribution

  • 09008737083618 ()


  • Cochlear implant system electrode array assembly

Insertion Electrode FLEX28 - 09008737083489

Insertion Electrode
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08348
In Commercial Distribution

  • 09008737083489 ()


  • Cochlear electrode array depth gauge, single-use

RONDO Control Unit anthracite - 09008737082840

Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08284
Not in Commercial Distribution

  • 09008737082840 ()


  • Cochlear implant/auditory brainstem implant sound processor

Insertion Electrode Compressed - 09008737082581

Insertion Electrode
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08258
In Commercial Distribution

  • 09008737082581 ()


  • Cochlear electrode array depth gauge, single-use

Insertion Electrode FLEX24 - 09008737082574

Insertion Electrode
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08257
In Commercial Distribution

  • 09008737082574 ()


  • Cochlear electrode array depth gauge, single-use

Insertion Electrode Medium - 09008737082567

Insertion Electrode
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08256
In Commercial Distribution

  • 09008737082567 ()


  • Cochlear electrode array depth gauge, single-use

Insertion Electrode FLEXsoft - 09008737082550

Insertion Electrode
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08255
In Commercial Distribution

  • 09008737082550 ()


  • Cochlear electrode array depth gauge, single-use

Ovation iX Iliac Stent Graft - M701TVIL142880J1

The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft is an endovascular device delivered via a small diameter 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 TriVascular Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
ENDOLOGIX, INC.
Iliac Limb
In Commercial Distribution

  • M701TVIL142880J1 ()

  • Catheter Gauge: 15 French
  • Length: 80 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 14 Millimeter
TV-IL142880-J

  • Abdominal aorta endovascular stent-graft
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