DEVICE: Sentiero Advanced (04260223145230)
Device Identifier (DI) Information
Sentiero Advanced
100340-SC-ALL
In Commercial Distribution
PATH medical GmbH
100340-SC-ALL
In Commercial Distribution
PATH medical GmbH
Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set
Content:
1. Case AN100503
2. Inlay Sentiero AN100677
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 DD-45 AN100306
8. Probe EP-DP Path long AN100028-US
9. Accessory box Sentiero Combo AN100261
10. ABR Quick SW AN100337-Quick
11. TEOAE Quick SW AN100109-Quick
12. DPOAE Quick SW AN100110-Quick
13. FMDPOAE SW AN100536
14. Tymp Class 2 SW AN100560
15. Audio Class 4 Advanced SW AN100653
16. Mira PC Patient Management SW AN100116
17. Label Printer SW AN100414
18. Power Supply Sentiero Advanced US AN101016+AN100993-USA
19. Tympanometry add-on TY-MA AN100947
20. Accessory box AB08 AN100734-P
21. Tympanometry cavity AN100549
22. Probe tip small PT-S AN100014-W (3 pcs.)
23. Probe tip medium PT-A AN100013 (5 pcs.)
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 35747 | Evoked-potential audiometer |
An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GWJ | Stimulator, Auditory, Evoked Response |
| EWO | Audiometer |
| ETY | Tester, Auditory Impedance |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6a03b03c-3c44-4653-a218-30155c55c83e
June 30, 2022
3
June 27, 2020
June 30, 2022
3
June 27, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined