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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 US4 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. Headphone Sennheiser HDA 280 calibrated, incl. EEPROM AN100117 8. Probe EP-DP Path AN 100028-US 9. Probe EP-DP BL AN 100530-US 10. Bone conductor B81 AN100888 or B71W AN100344 optionally 11. Patient button (Sentiero A) AN100343 12. 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 13. ASSR - 4 frequencies simultaneous AN100465 14. DPOAE Software AN100110 15. TEOAE Software AN100109 16. DPHiRES Software AN100537 17. FMDPOAE Software AN100536 18. DPOAE Threshold Estimation Software AN100111 19. Firmware PTA class 3 AN100114 20. 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 21. Software label printer AN100414 22. Accessory box Sentiero Screening AN100676 23. Power pack Sentiero Advanced AN101016 + 100993-USA FDA UDI
Model / Reference
100340-US4 FDA UDI
Description
Sentiero Advanced ABR US4 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. Headphone Sennheiser HDA 280 calibrated, incl. EEPROM AN100117 8. Probe EP-DP Path AN 100028-US 9. Probe EP-DP BL AN 100530-US 10. Bone conductor B81 AN100888 or B71W AN100344 optionally 11. Patient button (Sentiero A) AN100343 12. 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 13. ASSR - 4 frequencies simultaneous AN100465 14. DPOAE Software AN100110 15. TEOAE Software AN100109 16. DPHiRES Software AN100537 17. FMDPOAE Software AN100536 18. DPOAE Threshold Estimation Software AN100111 19. Firmware PTA class 3 AN100114 20. 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 21. Software label printer AN100414 22. Accessory box Sentiero Screening AN100676 23. Power pack Sentiero Advanced AN101016 + 100993-USA FDA UDI

Identifiers

Primary DI / UDI-DI
04260223141621 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 f7993437-0d1c-469e-a1a1-b4a237a03ce8 33 fields · synced Jun 1, 2026