Sentiero Desktop (Auditdata)

GUDID 04260223142819

Sentiero Desktop (Tymp Diagnostic)

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223142819
NIH Device Record Keyf3ebae98-1831-4f14-8aaa-2315a6336d17
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentiero Desktop (Auditdata)
Version Model Number100434-DW
Company DUNS551540334
Company NamePATH medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260223142819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWJStimulator, Auditory, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-26

Devices Manufactured by PATH medical GmbH

04260223147326 - nanoAudio DD452025-08-13 nanoAudio audiometer device with headphone DD45
04260223147333 - nanoAudio DD65v22025-08-13 nanoAudio audiometer device with headphone DD65v2
04260223147340 - nanoAudio Patient Response Button2025-08-13 Patient response button for nanoAudio
04260223147418 - Sentiero Screening 32025-08-13 Sentiero Screening3 Device with Touchscreen
04260223147449 - nanoAudio DD45 Set2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD45 device (101414-01) 2. English manual (101450-EN) 3. Lanyard (101458) 4.
04260223147456 - nanoAudio DD45 Set with Patient Response Button2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD45 device (101414-01) 2. English manual (101450-EN) 3. Lanyard (101458) 4.
04260223147463 - nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD45 device (101414-01) 2. English manual (101450-EN) 3. Lanyard (101458) 4.
04260223147470 - nanoAudio DD65v2 Set2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD65v2 device (101414-02) 2. English manual (101450-EN) 3. Lanyard (101458)

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