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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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Soft Medial Mixing Tips - 00850013007479

No Description
EARLENS CORPORATION
IDT04
In Commercial Distribution

  • 00850013007486 ()
  • 00850013007479 ()
IDT04

  • Earmould impression kit

Earlens Processor - 00850013007462

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

Soft Tipped Medial Mixing Tip(Blue) - 00850013007424

No Description
EARLENS CORPORATION
IDT03
Not in Commercial Distribution

  • 00850013007424 ()
  • 00850013007455 ()
IDT03

  • Dental material mixing nozzle

Earlens Fidelity Software - 00850013007417

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

Mixing Tips for 10ml Cartirdges - 00850013007400

No Description
EARLENS CORPORATION
IDT02
Not in Commercial Distribution

  • 00850013007400 ()
  • 00850013007448 ()
IDT02

  • Earmould, custom-made

Dispensing Tips (Blue) - 00850013007394

No Description
EARLENS CORPORATION
IDT01
Not in Commercial Distribution

  • 00850013007394 ()
  • 00850013007431 ()
IDT01

  • Dental material mixing nozzle

Impression Dispenser - 00850013007387

No Description
EARLENS CORPORATION
IDG01
In Commercial Distribution

  • 00850013007387 ()
IDG01

  • Earmould impression kit

Medial Impression Cartridges - 00850013007370

Medial Impression Cartridge, 3-Pack, IMC03, AS01052
EARLENS CORPORATION
IMC03
In Commercial Distribution

  • 00850013007356 ()
  • 00850013007370 ()
IMC03

  • Earmould impression material

Earlens Hybrid Impression Kit - 00850013007349

Includes - Medial Impression Cartridges - Lateral Impression Cartridges - Medial Mixing Tips - Lateral Mixing Tips
EARLENS CORPORATION
HIK02
In Commercial Distribution

  • 00850013007349 ()
HIK02

  • Earmould impression kit

Earlens Fitting Software, USB - 00850013007295

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
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