Ear Tip IT-02 Pack/50 pcs.

GUDID 04260223143212

Insert Earphone Tips

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223143212
NIH Device Record Key6a31b809-65e1-499e-b395-c3f9d8c39daf
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Tip IT-02 Pack/50 pcs.
Version Model Number100899-50
Company DUNS551540334
Company NamePATH medical GmbH
Device Count50
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
GS104260223143205 [Unit of Use]
GS104260223143212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-24
Device Publish Date2018-06-01

Devices Manufactured by PATH medical GmbH

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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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