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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 Contact Hearing Solution, Binaural - 00850013007288

Inductive Kit containing Left and Right Ear Tip & Processor Assemblies Left and Right Tympanic Lens Charger Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
IBK01
In Commercial Distribution

  • 00850013007288 ()
IBK01

  • Tympanic membrane contact hearing aid

Earlens Contact Hearing Solution, Monaural, Right - 00850013007271

Inductive Kit containing Right Ear Tip & Processor Assembly, Right Tympanic Lens, Charger. Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black,
EARLENS CORPORATION
IK01R
In Commercial Distribution

  • 00850013007271 ()
IK01R

  • Tympanic membrane contact hearing aid

Earlens Contact Hearing Solution, Monaural, Left - 00850013007264

Kit containing Left Ear Tip & Processor Assembly, Left Tympanic Lens, Charger. Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black,
EARLENS CORPORATION
IK01L
In Commercial Distribution

  • 00850013007264 ()
IK01L

  • Tympanic membrane contact hearing aid

Earlens Tympanic Lens, Binaural - 00850013007257

Inductive Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product box.
EARLENS CORPORATION
ITL01LR
In Commercial Distribution

  • 00850013007257 ()
  • 00850013007332 ()
ITL01LR

  • Tympanic membrane contact hearing aid tympanic transducer

Earlens Tympanic Lens - 00850013007240

Inductive Tympanic Lens L- left, R - Right
EARLENS CORPORATION
ITL01X
Not in Commercial Distribution

  • 00850013007240 ()
ITL01X

  • Tympanic membrane contact hearing aid tympanic transducer

Earlens Processor & Ear Tip - 00850013007233

Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, Ear Tip comes in L - Left, R - Right
EARLENS CORPORATION
PET01X
Not in Commercial Distribution

  • 00850013007233 ()
PET01X

  • Tympanic membrane contact hearing aid sound processor
  • Tympanic membrane contact hearing aid ear tip transmitter

Earlens Ear Tip, Binaural - 00850013007226

Inductive Ear Tip w/ left & right packaged
EARLENS CORPORATION
ET01LR
In Commercial Distribution

  • 00850013007226 ()
  • 00850013007318 ()
ET01LR

  • Tympanic membrane contact hearing aid ear tip transmitter

Earlens Ear Tip - 00850013007219

Inductive Ear Tip comes in L - Left, R - Right
EARLENS CORPORATION
ET01X
Not in Commercial Distribution

  • 00850013007219 ()
ET01X

  • Tympanic membrane contact hearing aid ear tip transmitter

Earlens Processor - 00850013007202

Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
IPR01XX
Not in Commercial Distribution

  • 00850013007202 ()
IPR01XX

  • Tympanic membrane contact hearing aid sound processor

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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