Ear Coupler Cable

GUDID 04260223143595

Ear Coupler Cable (PECC-HP)

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223143595
NIH Device Record Key21aac174-6992-4227-9473-00743da056ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Coupler Cable
Version Model Number100970
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 Kitfalse
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
GS104260223143595 [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 Date2020-01-29
Device Publish Date2020-01-21

On-Brand Devices [Ear Coupler Cable]

04260223143595Ear Coupler Cable (PECC-HP)
04260223143083Ear Coupler Cable (PECC-01)

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