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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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content: - carrying bag A/N100503 - USB Cable A/N100418 - AuDX PRO Flex A/N100434-AUPF - Probe EP-TY A/N100188-US - Insert Earphone Bio- Logic A/N100860-BL - Bone Conductor B71 A/N100344 - Gooseneck Microphone A/N100779 - FW Reflex & Tymp Class1 A/N100561 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMDPOAE A/N100536 - FW DPHiRES A/N100537 - FW Mira PC- Software A/N100116 - FW PTA3 A/N100114 - FW High Frequency A/N100454 - FW Magic A/N100112 - FW Labelprinter A/N100414 - Accessory Box Combo A/N100261 - Power Supply Senti/Sentiero Desktop US A/N100524 - User Manual A/N100904-EN-BL - Test Cavity Tymp A/N100549
PATH medical GmbH
100497-BLP1
Not in Commercial Distribution

  • 04260223143359 ()


  • Evoked-potential audiometer
Basic Set for AuDX branded Sentiero Content: - carrying bag A/N100503 - USB cable A/N100089 - AuDX A/N100098-AU - Headphone HB7/DD45 A/N100306-US - Probe EP-DP PATH long A/N100028-US - FW TEOAE Quick A/N100109-QUICK - FW DPOAE Quick A/N100110-QUICK - FW FMDPOAE A/N100536 - FW PTA Class 4 Advanced A/N100653 - FW Magic A/N100112 - FW Mira PC- Software A/N100116 - FW Labelprinter A/N100414 - Accessory box combo A/N100261 - Power Supply Sentiero US A/N100083-US - User Manual A/N100904-EN-BL
PATH medical GmbH
100250-BL1
Not in Commercial Distribution

  • 04260223143335 ()


  • Evoked-potential audiometer
ABR / ASSR electrode lead cable set
PATH medical GmbH
100891-1
In Commercial Distribution

  • 04260223143328 ()


  • Evoked-potential audiometer
AuDX PRO Flex branded Sentiero Desktop
PATH medical GmbH
100434-AUPF
In Commercial Distribution

  • 04260223143304 ()


  • Evoked-potential audiometer
AuDX PRO branded Sentiero
PATH medical GmbH
100098-AUP
In Commercial Distribution

  • 04260223143298 ()


  • Evoked-potential audiometer
AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer
Insert Earphone Tips
PATH medical GmbH
100840-250
Not in Commercial Distribution

  • 04260223143274 ()
  • 04260223143243 ()


  • Evoked-potential audiometer
Insert Earphone Tips
PATH medical GmbH
100900-100
In Commercial Distribution

  • 04260223143267 ()
  • 04260223143243 ()


  • Evoked-potential audiometer
Insert Earphone Tips
PATH medical GmbH
100900-50
Not in Commercial Distribution

  • 04260223143250 ()
  • 04260223143243 ()


  • Evoked-potential audiometer
Insert Earphone Tips
PATH medical GmbH
100899-250
Not in Commercial Distribution

  • 04260223143236 ()
  • 04260223143205 ()


  • Evoked-potential audiometer
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