Ear Tip PM013H Pack/100 pcs.

GUDID 04260223147005

13 mm mushroom ear tip, hard version

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223147005
NIH Device Record Key9d4b578c-9248-41fd-b6f6-4d112f40c8b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Tip PM013H Pack/100 pcs.
Version Model Number100771-PH-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
GS104260223146893 [Primary]
GS104260223147005 [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 Date2023-11-22
Device Publish Date2023-11-14

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04260223147418 - Sentiero Screening 32025-08-13 Sentiero Screening3 Device with Touchscreen
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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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