Sentiero Advanced NavPRO ONE 100340-BL-US1

GUDID 04260223143526

Sentiero NavPRO ONE Set: Content: 1. Sentiero Advance device AN100360-NPO 2. Carrying case AN100928 3. Inlay AN100677 4. Insert Earphone PIEP Bio-Logi

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223143526
NIH Device Record Keyc1f130fc-8086-433e-a62a-47e586cb815f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentiero Advanced NavPRO ONE
Version Model Number8-04-16550
Catalog Number100340-BL-US1
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 Kittrue
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
GS104260223143526 [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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-06-01

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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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