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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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Earlens Wireless Programmer - 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit

VITEK®2 - 03573026553968

VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
BIOMERIEUX , INC.
8.01
In Commercial Distribution

  • 03573026553968 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

Xprecia Stride™ Accessory Kit - 00630414001975

Stride Device Manager Application software kit
Siemens Healthcare Diagnostics Inc.
10714617
In Commercial Distribution

  • 00630414001975 ()
10714617

  • Medical equipment clinical data interfacing software

SOMNOSTAR - 10190752161993

SWR KIT SSPRO SOFTWARE VER 11
VYAIRE MEDICAL, INC.
28008-001
In Commercial Distribution

  • 10190752161993 ()
28008-001

  • Home-use sleep apnoea recording system

CareLink® - 00613994342805

SOFTWARE MMT-7335 CD-ROM CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00613994342805 ()


  • Patient health record information system application software

Accuguide® - 00613994161635

SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD
MEDTRONIC XOMED, INC.
8263005
In Commercial Distribution

  • 00613994161635 ()


  • Nerve-locating system

Kosmos OTS Android Doppler Software Package - 09353278000700

Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software

Axon - 09413000107500

Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system

VolparaDensity - 09421904268166

VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.1
In Commercial Distribution

  • 09421904268166 ()


  • Radiology DICOM image processing application software

VolparaDensity - 09421904268029

VolparaDensity 3.2 (Volpara Imaging Software 1.5.2)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.2
Not in Commercial Distribution

  • 09421904268029 ()


  • Radiology DICOM image processing application software
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