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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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This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ahead 500 CUBC1 Kit. Contains Device Identifier (DI) 00852745007277 - this is the DI for the BrainScope One (CUBC1) Device (BrainScope Part Number 50-1801-203)
Brainscope Company, Inc.
Ahead 500 CUBC1
In Commercial Distribution

  • 00852745007284 ()
BSO-3001

  • Electroencephalograph
BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the BrainScope One Device.
Brainscope Company, Inc.
Ahead 500
In Commercial Distribution

  • 00852745007239 ()
BSO-2001

  • Electroencephalograph
No Description
Brainscope Company, Inc.
99-1403-002
In Commercial Distribution

  • 00852745007123 ()


  • Electroencephalograph
BodyGuardian One Remote Monitoring System
PREVENTICE TECHNOLOGIES, INC.
BG3003
In Commercial Distribution

  • 00852132007248 ()


  • Medical networking interface unit
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, Tablet Assembly, WiFi
Great Lakes Neurotechnologies Inc.
502-0269, Tablet Assembly, WiFi
In Commercial Distribution

  • 00859584006010 ()


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

  • 00859584006003 ()


  • Tremor transducer
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