DEVICE: Sentiero Screening (04260223141423)
Device Identifier (DI) Information
Sentiero Screening
100250-US1
In Commercial Distribution
PATH medical GmbH
100250-US1
In Commercial Distribution
PATH medical GmbH
Sentiero Screening OAE + Audiometry Set
Content:
1. Case AN100503
2. Inlay Sentiero AN100677
3. USB data cable AN100089
4. Sentiero Screening device with touchscreen AN100098-S
5. Headphone HB7 / DD-45 AN100306-US
6. Probe EP-DP Path long AN100028-US
7. Pure Tone Audiometer Class 4A AN100653
8. DPOAE Quick Software AN100110-Quick
9. FMDPOAE Software AN100536
10. Software label printer AN100414
11. Accessory box Sentiero Screening AN100676
12. Power supply Sentiero US AN101013 + AN100993-USA
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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 |
---|---|
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 |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
079fde34-233a-4498-80fc-51bd8975b602
February 23, 2021
5
August 31, 2016
February 23, 2021
5
August 31, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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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