Identity
- Trade Name
- Sentiero Advanced FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Sentiero Advanced ABR US2 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. 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 10. DPOAE Software AN100110 11. TEOAE Software AN100109 12. DPHiRES Software AN100537 13. FMDPOAE Software AN100536 14. 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 15. Software label printer AN100414 16. Accessory box Sentiero Screening AN100676 17. Power pack Sentiero Advanced AN101016 + AN100993-USA FDA UDI
- Model / Reference
- 100340-US2 FDA UDI
- Description
- Sentiero Advanced ABR US2 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. 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 10. DPOAE Software AN100110 11. TEOAE Software AN100109 12. DPHiRES Software AN100537 13. FMDPOAE Software AN100536 14. 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 15. Software label printer AN100414 16. Accessory box Sentiero Screening AN100676 17. Power pack Sentiero Advanced AN101016 + AN100993-USA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223141607 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 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.
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- TE Tip Sample Box — Otodynamics · Class II
- Tip Sample Box (Neonate) — Otodynamics · Class II
- Otoport LCD service kit — Otodynamics · Class II
- TEOAE probe tips — Otodynamics · Class II
- ABR Case service kit - Top — Otodynamics · Class II
- Otoport ABR Binaural Upgrade Kit (TE) — Otodynamics · Class II
- ABR Test Cavity — Otodynamics · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI 5bf76a40-1ebf-44cb-b892-59855d0304ae 33 fields · synced May 30, 2026