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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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OrganOx metra - 05060462240029

The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146
In Commercial Distribution

  • 05060462240029 ()


  • Liver donor-organ preservation/transport system

FineTuner Echo & Battery - 09008737373429

Audio Processor Remote Control and Battery
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37342
In Commercial Distribution

  • 09008737373429 ()


  • Hearing aid/implant system remote control

AudioLink Main Unit - 09008737370282

Audio Processor Streaming Device
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37028
In Commercial Distribution

  • 09008737370282 ()


  • Hearing aid/implant system functionality-enhancing device

SONNET RCB Kit 4 Micro - 09008737341466

Audio Processor Rechargeable Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
34146
In Commercial Distribution

  • 09008737341466 ()


  • Portable/mobile rechargeable battery pack

SONNET RCB Kit 3 Standard - 09008737341442

Audio Processor Rechargeable Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
34144
In Commercial Distribution

  • 09008737341442 ()


  • Portable/mobile rechargeable battery pack

FineTuner - 09008737338077

Audio Processor Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33807
In Commercial Distribution

  • 09008737338077 ()


  • Hearing aid/implant system remote control

SONNET Mini Battery Pack Kit beige 75 cm - 09008737333836

Audio Processor Battery Pack Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33383
In Commercial Distribution

  • 09008737333836 ()


  • Cochlear implant/auditory brainstem implant battery

SONNET Mini Battery Pack Kit black 75 cm - 09008737333812

Audio Processor Battery Pack Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33381
In Commercial Distribution

  • 09008737333812 ()


  • Cochlear implant/auditory brainstem implant battery

SONNET Mini Battery Pack Kit anthracite 75 cm - 09008737333799

Audio Processor Battery Pack Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33379
In Commercial Distribution

  • 09008737333799 ()


  • Cochlear implant/auditory brainstem implant battery

SONNET Mini Battery Pack Kit beige 50 cm - 09008737333775

Audio Processor Battery Pack Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33377
In Commercial Distribution

  • 09008737333775 ()


  • Cochlear implant/auditory brainstem implant battery
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