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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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Access AFP Sample Diluent - H628332161

The Access AFP Sample Diluent is intended for use with the Access AFP assay to dilute patient samples containing AFP concentrations greater than the S6 calibrator.
Beckman Coulter, Inc.
33216
In Commercial Distribution

  • H628332161 ()
33216

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay

3100B HFOV - 50190752159882

Flexible Patient Circuit w/Filter for 3100B (FP730)
VYAIRE MEDICAL, INC.
29028-018
Not in Commercial Distribution

  • 50190752159882 ()
29028-018

  • Remotely-driven surgical/dental system drive cable

SAMBA 2 GO w/o manuals - 09008737532925

Audio Processor Streaming Device
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
53292
In Commercial Distribution

  • 09008737532925 ()


  • Hearing aid/implant system functionality-enhancing device

SAMBA 2 GO - 09008737525071

Audio Processor Streaming Device
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52507
In Commercial Distribution

  • 09008737525071 ()


  • Hearing aid/implant system functionality-enhancing device

RONDO 3 Telecoil Adapter & Case - 09008737394868

Audio Processor Telecoil Adapter
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
39486
In Commercial Distribution

  • 09008737394868 ()


  • Hearing aid/implant system functionality-enhancing device

AudioStream, Nordic Gray - 09008737372170

Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37217
In Commercial Distribution

  • 09008737372170 ()


  • Hearing aid/implant system functionality-enhancing device

AudioStream, Beige - 09008737372163

Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37216
In Commercial Distribution

  • 09008737372163 ()


  • Hearing aid/implant system functionality-enhancing device

AudioStream, White - 09008737372156

Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37215
In Commercial Distribution

  • 09008737372156 ()


  • Hearing aid/implant system functionality-enhancing device

AudioStream, Black - 09008737372149

Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37214
In Commercial Distribution

  • 09008737372149 ()


  • Hearing aid/implant system functionality-enhancing device

AudioStream, Ebony - 09008737372132

Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37213
In Commercial Distribution

  • 09008737372132 ()


  • Hearing aid/implant system functionality-enhancing device
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