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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 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
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