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Sentiero Advanced

FDA UDI

Class II (US FDA UDI)

by PATH medical GmbH

Identity

Trade Name
Sentiero Advanced FDA UDI
Generic Name
Evoked-potential audiometer FDA UDI
Device Name
Sentiero Advanced ABR US3 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Probe EP-DP Path AN100028-US 8. Headphone Sennheiser HDA 280 calibrated, incl. EEPROM AN100117 9. Bone conductor B81 calibrated AN100888 or B71W AN100344 optionally 10. Patient button (Sentiero A) AN100343 11. Binaural ABR Diagnostics SW, time saving up to 40%. Broadband Chirp and click Stimuli to be used with Headphone or Ear Probe or Oto insert phone. AN100424 12. Firmware PTA class 3 AN100114 13. DPOAE Software AN100110 14. TEOAE Software AN100109 15. DPHiRES Software AN100537 16. FMDPOAE Software AN100536 17. DPOAE Threshold Estimation Software AN100111 18. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 19. Software label printer AN100414 20. Accessory box Sentiero Screening AN100676 21. Power pack Sentiero Advanced AN101016 + AN100993-USA FDA UDI
Model / Reference
100340-US3 FDA UDI
Description
Sentiero Advanced ABR US3 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Probe EP-DP Path AN100028-US 8. Headphone Sennheiser HDA 280 calibrated, incl. EEPROM AN100117 9. Bone conductor B81 calibrated AN100888 or B71W AN100344 optionally 10. Patient button (Sentiero A) AN100343 11. Binaural ABR Diagnostics SW, time saving up to 40%. Broadband Chirp and click Stimuli to be used with Headphone or Ear Probe or Oto insert phone. AN100424 12. Firmware PTA class 3 AN100114 13. DPOAE Software AN100110 14. TEOAE Software AN100109 15. DPHiRES Software AN100537 16. FMDPOAE Software AN100536 17. DPOAE Threshold Estimation Software AN100111 18. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 19. Software label printer AN100414 20. Accessory box Sentiero Screening AN100676 21. Power pack Sentiero Advanced AN101016 + AN100993-USA FDA UDI

Identifiers

Primary DI / UDI-DI
04260223141614 FDA UDI
FDA Product Code
EWO FDA UDI
GWJ FDA UDI
GMDN Term
Evoked-potential audiometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1050 FDA UDI
882.1900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evoked-potential audiometer

Sentiero Advanced by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evoked-potential audiometer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PATH medical GmbH

Sources (1)

  • FDA UDI f5eb3e3f-5ff6-4cf5-90a6-d6137c614a6f 33 fields · synced Jun 8, 2026