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

  • 00850017421431 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
twiist Pump Starter Kit
SEQUEL MED TECH, LLC
DKPI-11029-007
In Commercial Distribution

  • 00850017421424 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
twiist Pump Assembly, Labeled
SEQUEL MED TECH, LLC
DKPI-21073-007
In Commercial Distribution

  • 00850017421400 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software
CytoVision V7.6 configuration
Leica Biosystems Richmond, Inc.
23SWR00076CV
Not in Commercial Distribution

  • 00849832013419 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision 7.5 Warranty upgrade DVD
Leica Biosystems Richmond, Inc.
23SWRWAR750
Not in Commercial Distribution

  • 00849832011620 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
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