Ear Coupler Set

GUDID 04260223143427

Ear Coupler Set (25 pcs.)

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223143427
NIH Device Record Key2d61e943-96f9-40f0-a76e-4571af7c28da
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Coupler Set
Version Model Number100890-25
Company DUNS551540334
Company NamePATH medical GmbH
Device Count25
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260223143410 [Unit of Use]
GS104260223143427 [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 Number1
Public Version Date2018-11-05
Device Publish Date2018-10-04

On-Brand Devices [Ear Coupler Set]

04260223143427Ear Coupler Set (25 pcs.)
04260223143410Ear Coupler Set (5 pcs.)

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