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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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BT12 ECG AHA WITH SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution

  • 05099169413337 ()
  • 15099169413334 ()


  • Electrocardiograph, professional, multichannel
BT-12 ECG IEC with SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution

  • 05099169413306 ()
  • 15099169413303 ()


  • Electrocardiograph, professional, multichannel
NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution

  • 15099590683276 ()
B91240

  • Laboratory instrument/analyser application software IVD
Cytomics FC 500 MPL with MXP Software
Beckman Coulter, Inc.
UPS (MPL)
In Commercial Distribution

  • 15099590572822 ()
626554

  • Flow cytometry analyser IVD, semi-automated
ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor
ABBOTT MOLECULAR INC.
4J94-23
In Commercial Distribution

  • 00884999039278 ()
4J94-23

  • Laboratory instrument/analyser application software IVD
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software
Software, TomoApps, Version 5.1.3 Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System.
ACCURAY INCORPORATED
1062424
In Commercial Distribution

  • M65810624240 ()
NA

  • Linear accelerator system
VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution

  • 03573026619060 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
BriefCase is a radiological computer aided triage and notification software device. Software version 3.0.0 for CSF triage
AIDOC MEDICAL LTD
3.0.0
Not in Commercial Distribution

  • 07290018052037 ()


  • Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage
AIDOC MEDICAL LTD
2.0.0
Not in Commercial Distribution

  • 07290018052020 ()


  • Radiology DICOM image processing application software
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