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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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CEREC Optispray
SIRONA Dental Systems GmbH
6144179
In Commercial Distribution

  • E27661441792 ()


  • Dental impression tray, single-use
Description: 4.5% CO2, 4% O2, Bal. N2; Cylinder: YD; Valve: CGA 973; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601024601 ()

  • Total Volume: 94 Liter
  • Pressure: 2000 Pound per Square Inch
Z03NI914YD0001

  • Calibration gas/non-refillable cylinder
Nucleus Smart App
COCHLEAR LIMITED
P1285539
In Commercial Distribution

  • 09321502043236 ()
P1285539

  • Audiometric/hearing device software
Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer
Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer
Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer
Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer
Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer
DreamMapper App iOS
Respironics, Inc.
DreamMapper iOS, North American Instance - 2
In Commercial Distribution

  • 00606959057692 ()
1101478

  • Self-care monitoring/reporting software
G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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