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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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ZR3 MNR, 2.4G NFM PB SABE/MSIL ZERENA 3
Bernafon AG
191292
In Commercial Distribution

  • 05711584086261 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR3 MNR, 2.4G NFM PB ANBR ZERENA 3
Bernafon AG
191290
In Commercial Distribution

  • 05711584086247 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR1 MNR T, 2.4G NFM DPB MAC ZERENA 1
Bernafon AG
191308
In Commercial Distribution

  • 05711584086230 ()


  • Air-conduction hearing aid, receiver-in-the-ear
A silicone lubricant that is latex compatible.
WESTRIDGE LABORATORIES INCORPORATED
Lush 4 fl oz Silicone Lubricant
In Commercial Distribution

  • 40864785000253 ()
  • 00864785000255 ()


  • Sexual lubricant
A silicone lubricant that is latex compatible.
WESTRIDGE LABORATORIES INCORPORATED
Lush 17 fl oz Silicone Lubricant
In Commercial Distribution

  • 30864785000232 ()
  • 00864785000231 ()


  • Sexual lubricant
A silicone lubricant that is latex compatible.
WESTRIDGE LABORATORIES INCORPORATED
Lush 8.5 fl oz Silicone Lubricant
In Commercial Distribution

  • 30864785000225 ()
  • 00864785000224 ()


  • Sexual lubricant
The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.
CEDARS-SINAI MEDICAL CENTER
2017
In Commercial Distribution

  • 00864687000247 ()


  • Image segmentation application software
The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.
CEDARS-SINAI MEDICAL CENTER
2015
In Commercial Distribution



  • Image segmentation application software
The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.
CEDARS-SINAI MEDICAL CENTER
2015
In Commercial Distribution

  • 00864687000209 ()


  • Image segmentation application software
ZR3 B 105, 2.4G NFM DPB MAC ZERENA 3
Bernafon AG
191315
In Commercial Distribution

  • 05711584086025 ()


  • Air-conduction hearing aid, behind-the-ear
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