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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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NA - 00840682146555

Half Workstation PC Assembly
GE Hualun Medical Systems Co., Ltd
5835165
In Commercial Distribution

  • 00840682146555 ()


  • Diagnostic x-ray digital imaging system workstation

SenoIris - 00840682140614

SenoIris 1 SP3.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682140614 ()


  • Diagnostic x-ray digital imaging system workstation

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

SICAT Function - D77664556410

Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation

SICAT Suite - D77664556330

No Description
SiCAT GmbH & Co. KG
6455633
Not in Commercial Distribution

  • D77664556330 ()
6455633

  • Diagnostic x-ray digital imaging system workstation

M12 System - 00815187020754

SD Card (GI Label)
GLOBAL INSTRUMENTATION, LLC
000-400-0129
In Commercial Distribution

  • 00815187020754 ()
000-400-0129

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020600

M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit 00815187020556; M5 Recorder 00815187020471; M5 4-Lead Patient Cable - RL Lead AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0195
In Commercial Distribution

  • 00815187020600 ()
009-400-0195

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020594

M5 Recorder, 3-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020457; M5 3-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0194
In Commercial Distribution

  • 00815187020594 ()
009-400-0194

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020587

M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5 2-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0193
In Commercial Distribution

  • 00815187020587 ()
009-400-0193

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020570

M5 Neck Lanyard
GLOBAL INSTRUMENTATION, LLC
009-400-0205
In Commercial Distribution

  • 00815187020570 ()
009-400-0205

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020563

M5 Recorder, USB Cable, USB Wall Charger, System Kit 00815187020556; M5 Recorder 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0192
In Commercial Distribution

  • 00815187020563 ()
009-400-0192

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020556

M5 Recorder
GLOBAL INSTRUMENTATION, LLC
M5
In Commercial Distribution

  • 00815187020556 ()
009-400-0180

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020549

M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0178
In Commercial Distribution

  • 00815187020549 ()
009-400-0178

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020471

M5 4-Lead Patient Cable - RL Lead AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0171
In Commercial Distribution

  • 00815187020471 ()
009-400-0171

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020457

M5 3-Lead Patient Cable AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0169
In Commercial Distribution

  • 00815187020457 ()
009-400-0169

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020440

M5 2-Lead Patient Cable AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0168
In Commercial Distribution

  • 00815187020440 ()
009-400-0168

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020433

M5 Patch Electrode, 2-Lead
GLOBAL INSTRUMENTATION, LLC
009-400-0167
In Commercial Distribution

  • 00815187020433 ()
009-400-0167

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020112

M5 Patient Cable Cradle
GLOBAL INSTRUMENTATION, LLC
009-400-0206
In Commercial Distribution

  • 00815187020112 ()
009-400-0206

  • Electrocardiographic ambulatory recorder

Messenger - 00086001142550

Messenger 6.0.0 Software Release
SPOK INC.
6.0.0
In Commercial Distribution

  • 00086001142550 ()


  • Alarm application software
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