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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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Accessory for Real Ear Measurement (REM), red
Interacoustics A/S
Sanibel REM Probe Tubes, type D
In Commercial Distribution

  • 05711117228571 ()
  • 05711117227581 ()
  • 05711117228533 ()
8533304 (50 pcs)

  • Audiometric/hearing aid tester
Accessory for Real Ear Measurement (REM), black
Interacoustics A/S
Sanibel REM Probe Tubes, type A
In Commercial Distribution

  • 05711117228557 ()
  • 05711117227550 ()
  • 05711117228458 ()
8533301 (50 pcs)

  • Audiometric/hearing aid tester
Medical device accessories intended for ABR measurements
Interacoustics A/S
Infant EarCup w/Tab electrodes
In Commercial Distribution

  • 05711117126006 ()
  • 05711117230055 ()
8049600

  • Evoked-potential audiometer
Accessory for Real Ear Measurement (REM)
Interacoustics A/S
REM Probe tubes
In Commercial Distribution

  • 05711117226478 ()
  • 05711117121742 ()
8104116 (50 pcs)

  • Audiometric/hearing aid tester
Accessory for Real Ear Measurement (REM), orange
Interacoustics A/S
REM Probe tubes
In Commercial Distribution

  • 05711117094206 ()
  • 05711117226485 ()
8500360 (40 pcs)

  • Audiometric/hearing aid tester
No Description
BIONIK, INC.
SE4HA4
In Commercial Distribution

  • 00860001346718 ()


  • Virtual-display rehabilitation system, powered-support, upper-limb
No Description
BIONIK, INC.
SE4
In Commercial Distribution

  • 00860001346701 ()


  • Virtual-display rehabilitation system, powered-support, upper-limb
No Description
MAYBEAM LLC
Premium W4
In Commercial Distribution

  • 00860000362320 ()


  • Patient monitoring system module, blood pressure, noninvasive
No Description
MAYBEAM LLC
Premium A1
In Commercial Distribution

  • 00860000362306 ()


  • Patient monitoring system module, blood pressure, noninvasive
UNITY 4 INSITU PACKAGE
Ws Audiology Usa, Inc.
UNITY 4
In Commercial Distribution

  • 05711781003160 ()
21031181

  • Audiometric/hearing aid tester
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