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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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U BAR DRAPE PACK
DEROYAL INDUSTRIES, INC.
89-10332
In Commercial Distribution

  • 50749756998364 ()
  • 00749756998369 ()
89-10332

  • General surgical procedure kit, non-medicated, single-use
KIT, G U MAJOR
Cardinal Health 200, LLC
PU5AMJKSC
In Commercial Distribution

  • 50195594917683 ()
  • 10195594917685 ()
PU5AMJKSC

  • General surgical procedure kit, medicated
ISODrape U DRAPE, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426099277 ()
  • 00748426099276 ()
  • 50748426099271 ()


  • Patient surgical drape, single-use
KIT,VASCULAR U BAR
Cardinal Health 200, LLC
PVOCAACO8
In Commercial Distribution

  • 50195594649768 ()
  • 10195594649760 ()
PVOCAACO8

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
Super Low (U) TRIAL
KURARAY NORITAKE DENTAL INC.
#4622-KA
In Commercial Distribution

  • EKUR004622KA1 ()


  • Dental composite resin
No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS™ App
In Commercial Distribution

  • 04719878879965 ()


  • Radiological PACS software
Windows Desktop based APP used to control Evok 1600 OTE/BTE device. A USB Bluetooth dongle will be used as an interface between the software and device. Also, remote support will be available through the APP to user to help with programming changes to improve their hearing needs.
Persona Medical
Persona APP Desktop
In Commercial Distribution

  • 00851362008148 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution

  • 00853858006379 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use
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