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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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The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
C4 IMAGING, LLC
F-01-01-0011
In Commercial Distribution

  • 00863593000228 ()


  • Brachytherapy source spacer
OASIS 26.0 CUTOM
Bernafon AG
185293
In Commercial Distribution

  • 05711584082843 ()


  • Audiometric/hearing device software
OASIS 26.0
Bernafon AG
185292
In Commercial Distribution

  • 05711584082836 ()


  • Audiometric/hearing device software
OASIS NXT 2017.2 CUSTOM
Bernafon AG
185291
In Commercial Distribution

  • 05711584082829 ()


  • Audiometric/hearing device software
OASIS NXT 2017.2
Bernafon AG
185290
In Commercial Distribution

  • 05711584082812 ()


  • Audiometric/hearing device software
CAPTO 5 MNR FW 1.0
Bernafon AG
182852
In Commercial Distribution

  • 05711584081471 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB SABE/MAC ACCUQ
Bernafon AG
182133
In Commercial Distribution

  • 05711584081402 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO5 MNR, 2.4G NFM PB ANBR ACCUQ
Bernafon AG
181980
In Commercial Distribution

  • 05711584081396 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO5 MNR, 2.4G NFM PB COBR ACCUQ
Bernafon AG
181979
In Commercial Distribution

  • 05711584081389 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO5 MNR, 2.4G NFM PB JEBL ACCUQ
Bernafon AG
181978
In Commercial Distribution

  • 05711584081372 ()


  • Air-conduction hearing aid, receiver-in-the-ear
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