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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 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
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
Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown LT comes in L - Left, R - Right
EARLENS CORPORATION
PLEL1X
Not in Commercial Distribution

  • 00850013007073 ()
PLEL1X

  • Tympanic membrane contact hearing aid ear tip transmitter
  • Tympanic membrane contact hearing aid sound processor
Light Tip w/ left & right packaged
EARLENS CORPORATION
LTEL1LR
Not in Commercial Distribution

  • 00850013007066 ()
  • 00850013007165 ()
LTEL1LR

  • Tympanic membrane contact hearing aid ear tip transmitter
Light Tip comes in L - Left, R - Right
EARLENS CORPORATION
LTEL1X
Not in Commercial Distribution

  • 00850013007059 ()
LTEL1X

  • Tympanic membrane contact hearing aid ear tip transmitter
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software
No Description
EARLENS CORPORATION
CHEL101
In Commercial Distribution

  • 00850013007035 ()
CHEL101

  • Noninvasive device battery charger
Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software
Kit containing 1 left Processor & Lght Tip that are connected together and 1 right Processor & Lght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown
EARLENS CORPORATION
PLEL1LR
Not in Commercial Distribution

  • 08500130070086 ()
  • 08500130070178 ()
PLEL1LR

  • Tympanic membrane contact hearing aid ear tip transmitter
  • Tympanic membrane contact hearing aid sound processor
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
ESL-Emerald-TN
U.S. OPHTHALMIC, L.L.C.
ESL-Emerald-TN
In Commercial Distribution

  • 00851158007683 ()


  • Ophthalmic tonometer, manual
No Description
U.S. OPHTHALMIC, L.L.C.
TN-180B
In Commercial Distribution

  • 00851158007119 ()


  • Ophthalmic tonometer, manual
No Description
U.S. OPHTHALMIC, L.L.C.
TN-150B
In Commercial Distribution

  • 00851158007102 ()


  • Ophthalmic tonometer, manual
The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers for the measurements of intraocular pressure of the human eye.
ZIEN MEDICAL TECHNOLOGIES, INC.
CATS-D
In Commercial Distribution

  • 00860412001558 ()
  • 00860412001541 ()
CATS-D

  • Ophthalmic tonometer, manual
The CATS Tonometer Prism (CATS) is a modified Goldmann applanation tonometer (GAT) prism that is optimized to work with the GAT's operating system to reduce errors in the measurement due to patient anatomical variation. This is used to measure intraocular pressure by applying a known force on the globe of the eye and measuring intraocular tension by applanation. Tonometer prisms are assembled onto a GAT as a patient contacting component that is then utilized by the GAT to assess intraocular pressure.
ZIEN MEDICAL TECHNOLOGIES, INC.
CATS-R
In Commercial Distribution

  • 00860412001510 ()


  • Ophthalmic tonometer, manual
IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea.
Trevi Technology, Inc.
AT
In Commercial Distribution

  • 00869228000441 ()


  • Ophthalmic tonometer, manual
Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip®
Fistula Solution Corporation
00860013000394
In Commercial Distribution

  • 00860013000394 ()
00860013000394

  • Ostomy convexity insert
No Description
Fistula Solution Corporation
00860013000325
In Commercial Distribution

  • 00860013000325 ()
  • 10860013000322 ()
00860013000325

  • Ostomy convexity insert
No Description
Fistula Solution Corporation
00860013000318
In Commercial Distribution

  • 10860013000315 ()
  • 00860013000318 ()
00860013000318

  • Ostomy convexity insert
No Description
Fistula Solution Corporation
00860013000301
In Commercial Distribution

  • 00860013000301 ()
  • 10860013000308 ()
00860013000301

  • Ostomy convexity insert
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