Ear Tip ET-S04 Pack/100 pcs.

GUDID 04260223145384

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223145384
NIH Device Record Keybd3b7c54-4caa-4272-84ac-c4e2dc43a76c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Tip ET-S04 Pack/100 pcs.
Version Model Number101019-100
Company DUNS551540334
Company NamePATH medical GmbH
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
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
GS104260223144837 [Primary]
GS104260223145384 [Unit of Use]

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 Number1
Public Version Date2020-07-06
Device Publish Date2020-06-27

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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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