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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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Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software
Kit containing 1 left Processor & Lght Tip that are connected together and 1 right Processor & Lght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown
EARLENS CORPORATION
PLEL1LR
Not in Commercial Distribution

  • 08500130070086 ()
  • 08500130070178 ()
PLEL1LR

  • Tympanic membrane contact hearing aid ear tip transmitter
  • Tympanic membrane contact hearing aid sound processor
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL40-16-4
Not in Commercial Distribution

34-TRL40-16-4

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL40-14-12
Not in Commercial Distribution

34-TRL40-14-12

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL40-14-8
Not in Commercial Distribution

34-TRL40-14-8

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL40-14-4
Not in Commercial Distribution

34-TRL40-14-4

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL40-12-12
Not in Commercial Distribution

34-TRL40-12-12

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL40-12-8
Not in Commercial Distribution

34-TRL40-12-8

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL40-12-4
Not in Commercial Distribution

34-TRL40-12-4

  • Surgical implant template, reusable
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