DEVICE: Sentiero Desktop Diagnostic (04260223142673)
Device Identifier (DI) Information
Sentiero Desktop Diagnostic
100497-US14
In Commercial Distribution
PATH medical GmbH
100497-US14
In Commercial Distribution
PATH medical GmbH
Sentiero Desktop Screening TY / Diagnostic Set US14
Content:
1. Carton for Sentiero Desktop AN100728
2. Sentiero Desktop (Tymp Diagnostic) AN100434-DG
3. USB data cable AN100418
4. Probe EP-TY long AN100188-US
5. Headphone Interacoustics DD-45 with HB7 calibrated, incl. EEPROM AN100306-US
6. Patient Response button AN100171
7. FW Screening Tymp class 2 AN100560
8. FW Tymp 1000 Hz AN100689
9. FW PTA class 3 AN100114
10. DPOAE Software AN100110
11. FMDPOAE Software AN100536
12. 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
13. Software label printer AN100414
14. Accessory box for Tymp probe AN100587
15. Accessory box AB08 AN100734-P
16. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally
17. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally
18. Test cavity tymp AN100549
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
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| Yes | |
| No | |
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| 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.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ETY | Tester, Auditory Impedance |
| EWO | Audiometer |
| GWJ | Stimulator, Auditory, Evoked Response |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K133012 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
4df14bdc-325f-4552-bef8-90e99ce03c0b
September 29, 2022
5
December 02, 2016
September 29, 2022
5
December 02, 2016
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