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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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No Description
EARLENS CORPORATION
ITL01R
In Commercial Distribution

  • 00850013007578 ()
ITL01R

  • Tympanic membrane contact hearing aid tympanic transducer
No Description
EARLENS CORPORATION
ITL01L
In Commercial Distribution

  • 00850013007561 ()
ITL01L

  • Tympanic membrane contact hearing aid tympanic transducer
No Description
EARLENS CORPORATION
ET01R
In Commercial Distribution

  • 00850013007554 ()
ET01R

  • Tympanic membrane contact hearing aid ear tip transmitter
No Description
EARLENS CORPORATION
ET01L
In Commercial Distribution

  • 00850013007547 ()
ET01L

  • Tympanic membrane contact hearing aid ear tip transmitter
No Description
EARLENS CORPORATION
IPR01BL
In Commercial Distribution

  • 00850013007530 ()
IPR01BL

  • Tympanic membrane contact hearing aid sound processor
No Description
EARLENS CORPORATION
IPR01SI
In Commercial Distribution

  • 00850013007523 ()
IPR01SI

  • Tympanic membrane contact hearing aid sound processor
No Description
EARLENS CORPORATION
IPR01CH
In Commercial Distribution

  • 00850013007516 ()
IPR01CH

  • Tympanic membrane contact hearing aid sound processor
Lateral Mixing Tip Kit (contains 7 Mixing Tips for 10ml Cartridges)
EARLENS CORPORATION
IDT05
In Commercial Distribution

  • 00850013007448 ()
  • 00850013007509 ()
IDT05

  • Earmould impression kit
Lateral Impression Cartridge, 6-pack, IMC04, AS01059
EARLENS CORPORATION
IMC04
In Commercial Distribution

  • 00850013007493 ()
  • 00850013007363 ()
IMC04

  • Earmould impression material
No Description
EARLENS CORPORATION
IDT04
In Commercial Distribution

  • 00850013007486 ()
  • 00850013007479 ()
IDT04

  • Earmould impression kit
Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
IPR02XX
Not in Commercial Distribution

  • 00850013007462 ()
IPR02XX

  • Tympanic membrane contact hearing aid sound processor
No Description
EARLENS CORPORATION
IDT03
Not in Commercial Distribution

  • 00850013007424 ()
  • 00850013007455 ()
IDT03

  • Dental material mixing nozzle
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software
No Description
EARLENS CORPORATION
IDT02
Not in Commercial Distribution

  • 00850013007400 ()
  • 00850013007448 ()
IDT02

  • Earmould, custom-made
No Description
EARLENS CORPORATION
IDT01
Not in Commercial Distribution

  • 00850013007394 ()
  • 00850013007431 ()
IDT01

  • Dental material mixing nozzle
No Description
EARLENS CORPORATION
IDG01
In Commercial Distribution

  • 00850013007387 ()
IDG01

  • Earmould impression kit
Medial Impression Cartridge, 3-Pack, IMC03, AS01052
EARLENS CORPORATION
IMC03
In Commercial Distribution

  • 00850013007356 ()
  • 00850013007370 ()
IMC03

  • Earmould impression material
Includes - Medial Impression Cartridges - Lateral Impression Cartridges - Medial Mixing Tips - Lateral Mixing Tips
EARLENS CORPORATION
HIK02
In Commercial Distribution

  • 00850013007349 ()
HIK02

  • Earmould impression kit
Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF002
Not in Commercial Distribution

  • 00850013007295 ()
ELF002

  • Audiometric/hearing device software
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
Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product box.
EARLENS CORPORATION
TLEL1LR
Not in Commercial Distribution

  • 00850013007103 ()
  • 00850013007189 ()
TLEL1LR

  • Tympanic membrane contact hearing aid tympanic transducer
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