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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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SONNET FM Battery Pack Cover anthracite - 09008737304928

Audio Processor Battery Pack Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30492
In Commercial Distribution

  • 09008737304928 ()


  • Cochlear implant/auditory brainstem implant battery

SONNET Battery Pack Frame - 09008737304676

Audio Processor Battery Pack Frame
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30467
In Commercial Distribution

  • 09008737304676 ()


  • Cochlear implant/auditory brainstem implant battery

RONDO 2 Processor Unit, SP - 09008737304607

Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30460
In Commercial Distribution

  • 09008737304607 ()


  • Cochlear implant/auditory brainstem implant sound processor

RONDO 2 Processor Unit - 09008737304591

Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30459
Not in Commercial Distribution

  • 09008737304591 ()


  • Cochlear implant/auditory brainstem implant sound processor

SONNET Control Unit anthracite - 09008737304539

Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30453
Not in Commercial Distribution

  • 09008737304539 ()


  • Cochlear implant/auditory brainstem implant sound processor

Mini Battery Pack for RONDO creme 100 cm - 09008737099909

Audio Processor Battery Pack
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09990
In Commercial Distribution

  • 09008737099909 ()


  • Cochlear implant/auditory brainstem implant battery

Mini Battery Pack for RONDO ebony 100 cm - 09008737099886

Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09988
In Commercial Distribution

  • 09008737099886 ()


  • Cochlear implant/auditory brainstem implant battery

Mini Battery Pack for RONDO ebony 27 cm - 09008737099879

Audio Processor Battery Pack
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09987
In Commercial Distribution

  • 09008737099879 ()


  • Cochlear implant/auditory brainstem implant battery

Mini Battery Pack for RONDO grey 27 cm - 09008737099855

Audio Processor Battery Pack Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09985
In Commercial Distribution

  • 09008737099855 ()


  • Cochlear implant/auditory brainstem implant battery

Access AFP - H628332111

The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Beckman Coulter, Inc.
33211
In Commercial Distribution

  • H628332111 ()
33211

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