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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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4Kscore Test - 00850038860004

4Kscore Specimen Collection Kit
Bioreference Health, LLC
1
In Commercial Distribution

  • 00850038860004 ()


  • Blood collection set, noninvasive

RECELL GO mini - 00851707004361

RECELL GO mini Autologous Cell Harvesting Device (Preparation Kit)
AVITA MEDICAL AMERICAS, LLC
AVRL0105
In Commercial Distribution

  • 00851707004361 ()


  • Autologous skin cell grafting kit

RECELL GO - 00851707004286

RECELL GO Autologous Cell Harvesting Device (Preparation Kit)
AVITA MEDICAL AMERICAS, LLC
AVRL0103
In Commercial Distribution

  • 00851707004286 ()


  • Autologous skin cell grafting kit

RECELL GO - 00851707004279

RECELL GO Autologous Cell Harvesting Device (Processing Device)
AVITA MEDICAL AMERICAS, LLC
AVRL0104
In Commercial Distribution

  • 00851707004279 ()


  • Autologous skin cell grafting kit

RECELL - 00851707004200

RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution

  • 00851707004200 ()
AVRL0101

  • Autologous skin cell grafting kit

RECELL - 00851707004149

RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution

  • 00851707004149 ()
C3RL01-B:US

  • Autologous skin cell grafting kit

Mi1250 SYNCHRONY 2 FLEX24 S-Vector Magnet - 09008737395438

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
39543
In Commercial Distribution

  • 09008737395438 ()
39571

  • Cochlear implant system electrode array assembly

Mi1250 SYNCHRONY 2 PIN FLEX24 S-Vector Magnet - 09008737395421

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
39542
In Commercial Distribution

  • 09008737395421 ()
39570

  • Cochlear implant system electrode array assembly

Mi1260 SONATA 2 FLEX24 - 09008737385439

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38543
In Commercial Distribution

  • 09008737385439 ()
38553

  • Cochlear implant system electrode array assembly

Mi1250 SYNCHRONY 2 FLEX24 - 09008737366803

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36680
In Commercial Distribution

  • 09008737366803 ()
36709

  • Cochlear implant system electrode array assembly
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