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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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N/A - 07613327509090

SURGICAL TABLET
STRYKER CORPORATION
0794001010
In Commercial Distribution

  • 07613327509090 ()
0794-001-010

  • Electronic surgical sponge-counter

Matrix Holter System - 90815187020399

M12A Enterprise System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020399 ()
005-400-0068

  • Electrocardiographic ambulatory recorder

GI Holter System - 90815187020375

M3R Holter Recorder
GLOBAL INSTRUMENTATION, LLC
M3R
In Commercial Distribution

  • 90815187020375 ()
001-400-0099

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020351

5 Lead Patient Cable, IEC, M3R
GLOBAL INSTRUMENTATION, LLC
001-400-0150
In Commercial Distribution

  • 90815187020351 ()
001-400-0150

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020191

M12R, 10 Lead Patient Cable
GLOBAL INSTRUMENTATION, LLC
001-400-0120
In Commercial Distribution

  • 90815187020191 ()
001-400-0120

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020719

M12R L Recorder, 10-Lead Cable, AHA, System Kit 90815187020184; M12R, 10 Lead patient Cable (DIN) 90815187020252; M12R Holter Recorder 90815187020320; M12R Carrying Case
GLOBAL INSTRUMENTATION, LLC
001-400-0123
In Commercial Distribution

  • 90815187020719 ()
001-400-0123

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020702

M12R Recorder, 7-Lead Cable AHA, System Kit 90815187020153; M12R, 7 Lead patient Cable (AHA) 90815187020252; M12R Holter Recorder 90815187020320; M12R Carrying Case
GLOBAL INSTRUMENTATION, LLC
001-400-0105
In Commercial Distribution

  • 90815187020702 ()
001-400-0105

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020696

M12R Recorder, 10-Lead Cable AHA, System Kit 90815187020191; M12R, 10 Lead Patient Cable 90815187020252; M12R Holter Recorder 90815187020320; M12R Carrying Case
GLOBAL INSTRUMENTATION, LLC
001-400-0107
In Commercial Distribution

  • 90815187020696 ()
001-400-0107

  • Electrocardiographic ambulatory recorder

GI Holter System - 90815187020429

M3R Intermittent and Continuous ECG Recorder
GLOBAL INSTRUMENTATION, LLC
M3R R
In Commercial Distribution

  • 90815187020429 ()
001-400-0152

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020382

M12A Office System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020382 ()
005-400-0067

  • Electrocardiographic ambulatory recorder
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