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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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DIB II Coil - 09008737041434

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
04143
Not in Commercial Distribution

  • 09008737041434 ()


  • Hearing implant implantable-component tester, postoperative

MAX Coil S - 09008737092726

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09272
In Commercial Distribution

  • 09008737092726 ()


  • Hearing implant implantable-component tester, postoperative

MAX Coil - 09008737092719

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09271
In Commercial Distribution

  • 09008737092719 ()


  • Hearing implant implantable-component tester, postoperative

Senographe Pristina - 00195278914026

Senographe Pristina UDI
GE MEDICAL SYSTEMS
MBE2
In Commercial Distribution

  • 00195278914026 ()


  • Stationary mammographic x-ray system, digital

Senographe Pristina 3D - 00195278194039

Kit upgrade HW Single PC Infinity
GE MEDICAL SYSTEMS
ATA2
In Commercial Distribution

  • 00195278194039 ()


  • Stationary mammographic x-ray system, digital

Tomosynthesis option - 04056869001005

Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography
Siemens Healthcare GmbH
11104944
In Commercial Distribution

  • 04056869001005 ()


  • Stationary mammographic x-ray system, digital

CPI-3 Clinical Programming Interface - 00840094406810

No Description
Advanced Bionics, LLC
CI-6101
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative

Clinician's Programming Interface - 00840094454330

No Description
Advanced Bionics, LLC
AB-6500
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative

SenoClaire - 00840682100076

SenoClaire LLH2
GE MEDICAL SYSTEMS
LLH2
Not in Commercial Distribution

  • 00840682100076 ()
5434135-5

  • Stationary mammographic x-ray system, digital

SenoClaire - 00840682100045

Digital Breast Tomosynthesis option for Senographe Essential
GE MEDICAL SYSTEMS
LLH1
Not in Commercial Distribution

  • 00840682100045 ()
5434135-4

  • Stationary mammographic x-ray system, digital
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