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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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Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
VIDAS PC V4.9 W10 Software version for clinic
BIOMERIEUX SA
4.9
In Commercial Distribution

  • 03573026619527 ()


  • Fluorescent immunoassay analyser IVD, laboratory
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.1
In Commercial Distribution

  • B9875X10 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.0
Not in Commercial Distribution

  • B9875X00 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
4.0
Not in Commercial Distribution

  • B9874X00 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
3.4
Not in Commercial Distribution

  • B9873X40 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
3.3
Not in Commercial Distribution

  • B9873X30 ()


  • Accelerator system quality assurance device
ALPHA MULTISTORE ACQUISITION BOX HD INCLUSIVE SOFTWARE "PERSONAL"
Gimmi GmbH
S.2046.60 HD
In Commercial Distribution

  • 04049047653516 ()
S.2046.60 HD

  • Endoscopic video imaging system
BD Pyxis MedBank Tower (MedPass Software v1.X)
CAREFUSION 303, INC.
SW-MP-V1
In Commercial Distribution

  • 10885403513817 ()


  • Anaesthesia cabinet
BD Pyxis Anesthesia Station 4000 (Software v6.X)
CAREFUSION 303, INC.
SW-PAS-4000-V6
In Commercial Distribution

  • 10885403513787 ()


  • Anaesthesia cabinet
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