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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
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
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