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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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SoftBank - 00810055812837

No Description
SCC SOFT COMPUTER
25.6.1.1
In Commercial Distribution

  • 00810055812837 ()


  • Blood bank information system application software

SoftID.Tx - 00810055812257

No Description
SCC SOFT COMPUTER
1.0.0.18
In Commercial Distribution

  • 00810055812257 ()


  • Bedside information system application software

Orthonol - 00885797019837

ORTHONOL(R) PREFORM NATURAL ARCH MX .017 X .025 34MM
Rmo, Inc.
A07075
In Commercial Distribution

  • 00000008857972 ()
  • 00885797019837 ()


  • Orthodontic archwire

Earlens ELF USB - 00850013007042

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

VITEK®2 - 03573026619060

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

NA - M65810624240

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

Pegasus Software License 512ch - 00850011306895

The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
512 Channel
In Commercial Distribution

  • 00850011306895 ()
36-0301-0045

  • Electroencephalographic monitoring system

Pegasus Software License 480ch - 00850011306888

The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
480 Channel
In Commercial Distribution

  • 00850011306888 ()
36-0301-0044

  • Electroencephalographic monitoring system

Pegasus Software License 448ch - 00850011306871

The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
448 Channel
In Commercial Distribution

  • 00850011306871 ()
36-0301-0043

  • Electroencephalographic monitoring system

Pegasus Software License 416ch - 00850011306864

The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
416 Channel
In Commercial Distribution

  • 00850011306864 ()
36-0301-0042

  • Electroencephalographic monitoring system
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