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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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Lancing Device, One Drop
INFORMED DATA SYSTEMS INC.
8300-10532
In Commercial Distribution

  • 00859509006057 ()


  • Manual blood lancing device, reusable
Test Strips, One Drop, 50ct
INFORMED DATA SYSTEMS INC.
8000-10510
In Commercial Distribution

  • 20859509006051 ()
  • 10859509006047 ()
  • 00859509006033 ()
  • 80859509006039 ()


  • Glucose monitoring system IVD, home-use
System Kit, Blood Glucose Meter, One Drop, mgd/L
INFORMED DATA SYSTEMS INC.
8000-10495
In Commercial Distribution

  • 10859509006023 ()
  • 00859509006026 ()


  • Glucose monitoring system IVD, home-use
Blood Glucose Meter, One Drop, mg/dL
INFORMED DATA SYSTEMS INC.
8000-10465
In Commercial Distribution

  • 00859509006019 ()


  • Glucose monitoring system IVD, home-use
Kinesia One, Application Software
Great Lakes Neurotechnologies Inc.
360-0040, Application Software
In Commercial Distribution

  • 00859584006119 ()


  • Tremor transducer
Kinesia One, Tablet Assembly, WiFi plus Cellular
Great Lakes Neurotechnologies Inc.
502-0270, Tablet Assembly, WiFi plus Cellular
In Commercial Distribution

  • 00859584006041 ()


  • Tremor transducer
Kinesia One, WiFi plus Cellular
Great Lakes Neurotechnologies Inc.
700-0019-1, WiFi plus Cellular
In Commercial Distribution

  • 00859584006034 ()


  • Tremor transducer
Kinesia One, Sensor Assembly
Great Lakes Neurotechnologies Inc.
502-0263, Sensor Assembly
In Commercial Distribution

  • 00859584006027 ()


  • Tremor transducer
Kinesia One System, WiFi
Great Lakes Neurotechnologies Inc.
700-0019, WiFi
In Commercial Distribution

  • 00859584006003 ()


  • Tremor transducer
Lancets, 33G, 100CT, Boxed, One Drop, US-UK
INFORMED DATA SYSTEMS INC.
8000-10556
In Commercial Distribution

  • 00859509006118 ()


  • Blood lancing device tip
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