DEVICE: Sentiero Desktop Diagnostic (04260223141553)

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Device Identifier (DI) Information

Sentiero Desktop Diagnostic
100497-US9

PATH medical GmbH
04260223141553
GS1
1
Sentiero Desktop Diagnostic Set US9 Diagnostic OAE with Diagnostic Tymp, Audio, DPOAE Threshold estimation software, Simultaneous DPOAE measurements on both ears (two probes incl.) Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. Probe EP-DP VIP blue AN100539-US 5. DD45 HB7 headphone (calibrated) AN100306-US 6. Bone conductor B71 (calibrated) AN100344 7. Gooseneck microphone AN100779 8. FW Reflex & Tymp class1 AN100561 9. Software label printer AN100414 10. Label printer cable Senti / Sentiero desktop AN100417 11. DPOAE Software AN100110 12. TEOAE Software AN100109 13. DPHiRES Software AN100537 14. FMDPOAE Software AN100536 15. DPOAE Threshold Estimation Software AN100111 16. 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 17. FW Live AN100825 18. UT-08 Spondee Words for Children (English) AN100819 19. UT-10 Spondee Words for Adults (English) AN100821 20. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 21. UT-12 Central Institute for the Deaf W22 AN100823 22. UT-13 PBK-50 (English) AN100824 23. Accessory box for Tymp probe AN100587 24. Accessory box Sentiero (Grason) AN100734 25. Power supply Senti / Sentiero Desktop FW7662M AN100524 26. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS. AN100525-USA/-UK/-EU/-AUS 27. Test cavity tymp AN100549 28. PTA Class 3 Software AN100114
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
EWO Audiometer
GWJ Stimulator, Auditory, Evoked Response
ETY Tester, Auditory Impedance
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Device Status

In Commercial Distribution
September 16, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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