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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ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL3
In Commercial Distribution

  • 50195594700971 ()
  • 10195594700973 ()
SBA11LLSL3

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
A digital epilepsy care management platform application for iOS.
Ai Nile Inc
Nile for iOS
In Commercial Distribution

  • 00850031821002 ()


  • Medication reminder application software
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Tandem Diabetes Care, Inc.
1007111
In Commercial Distribution

  • 90850018992452 ()


  • Ambulatory insulin infusion pump software, data-display
  • Ambulatory insulin infusion pump remote control
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747162899 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747162882 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747177008 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747176995 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
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