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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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ASI IVD System - 07290016630039

ASI IVD System with software version GenASIs V-8.3
APPLIED SPECTRAL IMAGING LTD.
GenASIs 8.3
In Commercial Distribution

  • 07290016630039 ()


  • Laboratory analyser operation system software IVD

GenASIs™ System - 07290016630015

No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630015 ()


  • Laboratory analyser operation system software IVD

GenASIs™ System - 07290016630008

No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630008 ()


  • Laboratory analyser operation system software IVD

Microwave Ablation Generator - 06954414674453

Microwave Ablation Generator
Canyon Medical Inc.
KY-2100A
In Commercial Distribution

  • 06954414674453 ()


  • Microwave hyperthermia system

Welch Allyn, Inc. - 00732094257748

XScribe/RScribe Server - version 6, current software CD; Software kit; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094257748 ()
XSERV-6AA-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Earlens ELF USB - 08500130070192

Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software

iGUIDE - 04056719002190

iGUIDE is the control software of the HexaPOD™ evo RT Couchtop. Software Revison 2.2.3 includes security patch.
3C-Medical Intelligence GmbH
P10603-111-223
In Commercial Distribution

  • 04056719002190 ()
P10603-111

  • Accelerator system table, powered

Vinehealth Cancer Companion - 05070000764115

No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution

  • 05070000764115 ()


  • Medication reminder application software
  • Clinical management support software

Roentgen Files - 00850631008506

Roentgen Files 4.1.1
Brit Systems, LLC
4.1.1
In Commercial Distribution

  • 00850631008506 ()


  • Radiological PACS software
  • Radiology information system application software

Roentgen Files - 00850631008087

Roentgen Files 4.1.0
Brit Systems, LLC
4.1.0
In Commercial Distribution

  • 00850631008087 ()


  • Radiological PACS software
  • Radiology information system application software
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