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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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Neuro Cochlear Implant System - 03663227004014

Programming Device, Left Wired
NEURELEC
159689
In Commercial Distribution

  • 03663227004014 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227004007

Programming Device, Right Wired
NEURELEC
173414
In Commercial Distribution

  • 03663227004007 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227001976

CI-LINK OPERATING ROOM KIT (ZTI)
NEURELEC
178380
In Commercial Distribution

  • 03663227001976 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227001969

CI-LINK FITTING ROOM KIT
NEURELEC
178379
In Commercial Distribution

  • 03663227001969 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227001952

CI-Link exchange
NEURELEC
178378
In Commercial Distribution

  • 03663227001952 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227001532

Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227000894

CI-Link Unit Programming System
NEURELEC
177545
In Commercial Distribution

  • 03663227000894 ()


  • Hearing aid/implant system programming interface unit

ANAEYES OCT for system linkage - 03615020000496

No Description
ESSILOR INTERNATIONAL
ANAEYES OCT
In Commercial Distribution

  • 03615020000496 ()


  • Camera application software

Earlens Wireless Updater - 08500130070000

Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit

Earlens Wireless Programmer - 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit
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