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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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i-Dixel - 04548213024728

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213024728 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213024704

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213024704 ()


  • Basic diagnostic x-ray system application software

Unyvero - 04260364750027

User interface and instrument to control Unyvero Application workflow in combination with Unyvero L4 Lysator(s) and Unyvero A50 Analyzer(s)
Curetis GmbH
C8 Cockpit
Not in Commercial Distribution

  • 04260364750027 ()
60003

  • Laboratory instrument/analyser control unit IVD

SCINTRON - 04260484140050

Gamma Camera Workstation for Acquisition, Reviewing and Processing
MiE medical imaging electronics GmbH
SCINTRON
In Commercial Distribution

  • 04260484140050 ()


  • Nuclear medicine system operator console, multi-purpose

ECAT Scintron PET - 04260484140029

Nuclear Medicine Workstation for Aquisition, Viewing and Processing
MiE medical imaging electronics GmbH
ECAT Scintron PET
In Commercial Distribution

  • 04260484140029 ()


  • Nuclear medicine system operator console, multi-purpose

Remidio - 08906096520038

Remidio Microscope Recording device MRD-10 is a device attached to a surgical microscope & is used for the video recording of the surgeries related to the eye with an inherent simplicity built in its operation & use.MRD-10 device enables 4k resolution and 60FPS recording using high-resolution optics & i Phone.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
MRD-10
In Commercial Distribution

  • 08906096520038 ()
650711448

  • Surgical microscope video camera, non-sterilizable

Nucleus - 09321502006637

CRYSTAL INTEGRITY TEST SYSTEM
COCHLEAR LIMITED
Z60033
In Commercial Distribution

  • 09321502006637 ()
Z60033

  • Hearing implant implantable-component tester, postoperative

Cochlear™ Research Platform - 09321502044059

Version 1.0
COCHLEAR LIMITED
P1479694
In Commercial Distribution

  • 09321502044059 ()
P1479694

  • Hearing implant implantable-component tester, postoperative

Cochlear Integrity Test Unit - 09321502033770

No Description
COCHLEAR LIMITED
S428163
In Commercial Distribution

  • 09321502033770 ()
S428163

  • Hearing implant implantable-component tester, postoperative

Nucleus - 09321502027809

Cochlear Nucleus Intergrity Test System
COCHLEAR LIMITED
S264916
In Commercial Distribution

  • 09321502027809 ()
ITSYS

  • Hearing implant implantable-component tester, postoperative
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