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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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WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177046 ()


  • SPECT system application software
WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177039 ()


  • SPECT system application software
WBR Imaging X + X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177022 ()


  • SPECT system application software
WBR Imaging X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177015 ()


  • SPECT system application software
WBR Imaging X
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177008 ()


  • SPECT system application software
Oticon Genie 2 2021.2
Sbo Hearing A/S
228229
In Commercial Distribution

  • 05714464013104 ()


  • Audiometric/hearing device software
Oticon Genie 2 2021.2 VA
Sbo Hearing A/S
228227
In Commercial Distribution

  • 05714464013081 ()


  • Audiometric/hearing device software
AudigyFit 2 2021.2
Sbo Hearing A/S
228223
In Commercial Distribution

  • 05714464013043 ()


  • Audiometric/hearing device software
Bernafon OasisNxt 2021.2
Sbo Hearing A/S
228221
In Commercial Distribution

  • 05714464013036 ()


  • Audiometric/hearing device software
OasisNxt Custom 2021.2
Sbo Hearing A/S
228220
In Commercial Distribution

  • 05714464013029 ()


  • Audiometric/hearing device software
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