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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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vW CoFactor Opti8 Software
CHRONO-LOG CORP
vW CoFactor Opti8 Software
In Commercial Distribution

  • 00811476011670 ()


  • Platelet aggregation analyser IVD
AGGRO/LINK Opti8 Software
CHRONO-LOG CORP
AGGRO/LINK Opti8 Software
In Commercial Distribution

  • 00811476011663 ()


  • Platelet aggregation analyser IVD
AGGRO/LINK WBA Software
CHRONO-LOG CORP
AGGRO/LINK WBA Software
In Commercial Distribution

  • 00811476011007 ()


  • Platelet aggregation analyser IVD
M12A Enterprise System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020399 ()
005-400-0068

  • Electrocardiographic ambulatory recorder
M12A Office System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020382 ()
005-400-0067

  • Electrocardiographic ambulatory recorder
FLUOROSCOPY SOFTWARE 2.3 - ENABLE
Stryker Leibinger GmbH & Co. KG
6004-650-300
In Commercial Distribution

  • 07613154637164 ()
6004-650-300

  • Robotic surgical navigation system application software
SPINEMAP¿ 3D 3.1 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-680-000
In Commercial Distribution

  • 07613327359954 ()
6002-680-000

  • Surgical planning/navigation-enhancement system
Medical Device Software Application
Airstrip Technologies, Inc.
2003
In Commercial Distribution

  • B15320030 ()


  • Bedside monitor remote-viewing software, physiological parameter
PROFESS(TM) SOFTWARE ENABLE
Stryker Leibinger GmbH & Co. KG
6001-400-300
In Commercial Distribution

  • 07613327286755 ()
6001-400-300

  • Robotic surgical navigation system application software
Software Eli Edit Standard
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655023267 ()
107420

  • Electrocardiograph, professional, multichannel
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