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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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Sky CI™ M90 Sound Processor - 00840094453562

Lava Red
Advanced Bionics, LLC
CI-5295-280
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor

Naida™ CI M90 Sound Processor - 00840094453494

Resin Beige
Advanced Bionics, LLC
CI-5293-240
In Commercial Distribution



  • D-dimer IVD, control

Naida™ CI M90 Sound Processor - 00840094453487

Alpine White
Advanced Bionics, LLC
CI-5293-110
In Commercial Distribution



  • D-dimer IVD, control

Naida™ CI M90 Sound Processor - 00840094453470

Velvet Black
Advanced Bionics, LLC
CI-5293-150
In Commercial Distribution



  • D-dimer IVD, control

Naida™ CI M90 Sound Processor - 00840094453463

Silver Gray
Advanced Bionics, LLC
CI-5293-140
In Commercial Distribution



  • D-dimer IVD, control

Naida™ CI M90 Sound Processor - 00840094453456

Chestnut
Advanced Bionics, LLC
CI-5293-130
In Commercial Distribution



  • D-dimer IVD, control

Naida™ CI M90 Sound Processor - 00840094453449

Sand Beige
Advanced Bionics, LLC
CI-5293-120
In Commercial Distribution



  • D-dimer IVD, control

3D Magnet - 00840094453425

Plus
Advanced Bionics, LLC
CI-7523-006
In Commercial Distribution



  • Hearing implant system external magnet, reusable

3D Headpiece Magnet Kit - 00840094453418

No Description
Advanced Bionics, LLC
CI-7527
In Commercial Distribution



  • Hearing implant system external magnet, reusable

3D Magnet Max - 00840094453395

No Description
Advanced Bionics, LLC
CI-7523-005
In Commercial Distribution



  • Hearing implant system external magnet, reusable
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