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

  • 00850013007240 ()
ITL01X

  • Tympanic membrane contact hearing aid tympanic transducer
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
Inductive Ear Tip w/ left & right packaged
EARLENS CORPORATION
ET01LR
In Commercial Distribution

  • 00850013007226 ()
  • 00850013007318 ()
ET01LR

  • Tympanic membrane contact hearing aid ear tip transmitter
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
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
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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