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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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Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9158 IOS (Version 13)
In Commercial Distribution

  • 00300021177553 ()
MA9158001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9140 IOS (Version 12)
In Commercial Distribution

  • 00300021175559 ()
MA9140001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9135 ANDROID (Version 12)
In Commercial Distribution

  • 00300021174552 ()
MA9135001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
No Description
HELENA LABORATORIES CORPORATION
1673001
In Commercial Distribution

  • M52516730010 ()


  • Densitometry analyser IVD
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
OMST1065
In Commercial Distribution

  • 00889024596078 ()

  • Width: 65.00 Inch
OMST1065

  • Touchscreen
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
OMST1050
In Commercial Distribution

  • 00889024596061 ()

  • Width: 50.00 Inch
OMST1050

  • Touchscreen
AM Systems SCC Touchscreen Monitor
ABBOTT MOLECULAR INC.
02J11-056
In Commercial Distribution

  • 00884999048843 ()
02J11-056

  • Touchscreen
The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s).
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Controller (6.0/W10 loT)
In Commercial Distribution

  • 09349458004859 ()
S21.4621

  • Microscope slide stainer IVD
No Description
HELENA LABORATORIES CORPORATION
1679000
In Commercial Distribution

  • M52516790000 ()


  • Densitometry analyser IVD
Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of care: i) to capture and digitally record images of fluorescence emitted from a wound when exposed to excitation light and ii) to capture and digitally record images through measuring surface temperature distribution.
Swift Medical Inc
SV403
In Commercial Distribution

  • 00627987231151 ()


  • Infrared thermography system
  • Fluorescence wound imaging unit
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