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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 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

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

Vinehealth Cancer Companion - 05070000764115

No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution

  • 05070000764115 ()


  • Medication reminder application software
  • Clinical management support software

Scenium - 04056869041087

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909201
In Commercial Distribution

  • 04056869041087 ()


  • SPECT system application software
  • PET system application software

syngo.SPECT Processing - 04056869041070

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909200
In Commercial Distribution

  • 04056869041070 ()


  • PET system application software
  • SPECT system application software

syngo.MI Neurology - 04056869041056

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909198
In Commercial Distribution

  • 04056869041056 ()


  • PET system application software
  • SPECT system application software

syngo.PET&CT Oncology - 04056869041032

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909196
In Commercial Distribution

  • 04056869041032 ()


  • PET system application software
  • SPECT system application software

syngo.CT Lung CAD (US+CN) - 04056869027456

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764034
In Commercial Distribution

  • 04056869027456 ()


  • SPECT system application software
  • PET system application software

syngo.CT Lung CAD (ROW excl. US+CN) - 04056869027449

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764033
In Commercial Distribution

  • 04056869027449 ()


  • SPECT system application software
  • PET system application software
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