DEVICE: Sentiero Desktop Diagnostic (04260223141560)

Device Identifier (DI) Information

Sentiero Desktop Diagnostic
100497-US11
In Commercial Distribution

PATH medical GmbH
04260223141560
GS1

1
551540334 *Terms of Use
Sentiero Desktop Screening TY / Diagnostic Set US11 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. FW Screening Tymp class 2 AN100560 6. Software label printer AN100414 7. DPOAE Software AN100110 8. TEOAE Software AN100109 9. DPHiRES Software AN100537 10. FMDPOAE Software AN100536 11. Accessory box for Tymp probe AN100587 12. Accessory box Sentiero (Grason) AN100734 13. Power supply Senti / Sentiero Desktop FW7662M AN100524 14. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS. AN100525-USA/-UK/-EU/-AUS 15. Test cavity tymp AN100549
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

027ec6d6-0471-4da0-8e54-f809cff53b2c
March 29, 2018
2
August 31, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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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