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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
OPTOS PUBLIC LIMITED COMPANY
OCT
In Commercial Distribution

  • 05057056003856 ()
000385

  • Scanning-laser retinal imaging system
No Description
SENSIUM HEALTHCARE LIMITED
US Patch
In Commercial Distribution

  • 05060403780065 ()
  • 05060403780058 ()
  • 05060403780041 ()
TZ202055

  • Nurse call system
Handheld, portable, Otoacoustic Emission (OAE) analyser, for hearing screening applications. Otoport Pro OAE device only. Part code used for reference/regulatory purposes. Device sold only with system, unless replacement.
OTODYNAMICS LIMITED
OPRO-O
In Commercial Distribution

  • 05060396173448 ()


  • Evoked-potential audiometer
Handheld, portable, Automated Auditory Brainstem Response (AABR) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, system items, and ABR Screener licence
OTODYNAMICS LIMITED
OPRO-SCR-A
In Commercial Distribution

  • 05060396173219 ()


  • Evoked-potential audiometer
OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-A
In Commercial Distribution

  • 05060396173127 ()


  • Evoked-potential audiometer
ABR electrodes cable for use with TAB electrodes, length 47"/1.2m, Black/Green/White colour coding for NHSP, right-angle yellow 4-pin plug, for use with Otoport Pro
OTODYNAMICS LIMITED
OPRO-NEC
In Commercial Distribution

  • 05060396173066 ()


  • Evoked-potential audiometer
ABR electrodes cable for use with TAB electrodes, length 47"/1.2m, Red/Black/White color coding, right-angle yellow 4-pin plug, for use with Otoport Pro
OTODYNAMICS LIMITED
OPRO-TEC
In Commercial Distribution

  • 05060396172380 ()


  • Evoked-potential audiometer
ABR electrodes cable for use with 4mm SNAP electrodes, length 47"/1.2m, Red/Black/White color coding, right-angle yellow 4-pin plug, for use with Otoport Pro
OTODYNAMICS LIMITED
OPRO-SEC
In Commercial Distribution

  • 05060396172373 ()


  • Evoked-potential audiometer
ABR electrode cable for use with TAB electrodes, length 44"/1.1M, Red/Black/White color coding, straight yellow 4-pin plug, for use with OtoNova Pro
OTODYNAMICS LIMITED
NPRO-TEC
In Commercial Distribution

  • 05060396172366 ()


  • Evoked-potential audiometer
ABR electrode cable for use with 4mm SNAP electrodes, length 44"/1.1M, Red/Black/White color coding, straight 4-pin yellow plug, for use with OtoNova Pro
OTODYNAMICS LIMITED
NPRO-SEC
In Commercial Distribution

  • 05060396172359 ()


  • Evoked-potential audiometer
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