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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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Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC6000
In Commercial Distribution

  • 06945040101406 ()


  • Electrocardiographic ambulatory recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-032908-00
In Commercial Distribution

  • 06944904086415 ()


  • Patient monitoring system module, printing
Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
STERIS CORPORATION
ORLocate Tablet
In Commercial Distribution

OX216

  • Electronic surgical sponge-counter
Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
Steris Corporation
ORLocate Tablet
Not in Commercial Distribution

  • 00724995220679 ()
OX216

  • Electronic surgical sponge-counter
No Description
ORTHO KINEMATICS, INC.
2
In Commercial Distribution

  • 00868579000209 ()


  • Diagnostic x-ray digital imaging system workstation
PAPER ROLLS, 100MM WIDE,ECG
PHYSIO-CONTROL, INC.
11240
Not in Commercial Distribution

  • 00681490597722 ()
11240-000016

  • Patient monitoring system module, printing
PAPER-ELECTROCARDIOGRAM,RECORDING
PHYSIO-CONTROL, INC.
11240
In Commercial Distribution

  • 00681490595896 ()
11240-000013

  • Patient monitoring system module, printing
No Description
IRHYTHM TECHNOLOGIES, INC.
DFG0001
In Commercial Distribution

  • 00869770000241 ()


  • Electrocardiographic ambulatory recorder
ZIO SR ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
K100A101X
Not in Commercial Distribution

  • 00869770000234 ()


  • Electrocardiographic ambulatory recorder
ZIO AT ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
A100A100X
In Commercial Distribution

  • 00869770000210 ()


  • Electrocardiographic ambulatory recorder
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