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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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PCD, VertaPlex - 07613327357868

Precision System with Extension Tube and Bone Cement
STRYKER CORPORATION
0507486000
In Commercial Distribution

  • 37613327357869 ()
  • 07613327357868 ()

  • Angle: 90.0 degree
0507-486-000

  • Orthopaedic cement preparation/delivery kit

TOMOCAP - 04059237000747

No Description
Heidelberg Engineering GmbH
N/A
In Commercial Distribution

  • 04059237000747 ()
  • 04059237000860 ()
18829

  • Eye anterior segment analyser

twiist - 00850017421448

twiist Disposable Cassette Pack (Sterile)
SEQUEL MED TECH, LLC
DKPI-11099-001
In Commercial Distribution

  • 00850017421431 ()
  • 00850017421448 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

twiist - 00850017421431

twiist Disposable Cassette
SEQUEL MED TECH, LLC
DKPI-11073-001
In Commercial Distribution

  • 00850017421431 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Pod - 10385083000527

Omnipod 5 Pod
Insulet Corporation
POD-OMNI-I1-6720
In Commercial Distribution

  • 20385083000531 ()
  • 10385083000527 ()
  • 20385083000579 ()
  • 20385083000753 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Pod - 10385083000114

Omnipod 5 Pod
Insulet Corporation
POD-BLE-H1-520
In Commercial Distribution

  • 10385083000213 ()
  • 10385083000114 ()
  • 10385083000138 ()
  • 20385083000210 ()
  • 20385083000135 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

PreOp - 05430000733007

PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
1.0.0
Not in Commercial Distribution

  • 05430000733007 ()


  • Bioelectrical signal analysis software

Natus - 00382830022279

Neuroworks/Sleepworks 8.1.1 GMA3 US DVD
XLTEK
016049
In Commercial Distribution

  • 00382830022279 ()


  • Electroencephalograph

Natus - 00382830022262

Neuroworks/Sleepworks 8.1.0 GMA3 Int'l DVD
XLTEK
016048
In Commercial Distribution

  • 00382830022262 ()


  • Electroencephalograph

Natus - 00382830022255

NEUROWORKS 8.0.1 US DVD
XLTEK
013192
In Commercial Distribution

  • 00382830022255 ()


  • Electroencephalograph
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