EarDome

GUDID 00062790870072

EarDomes (2 pack) for use with Vivosonic Screener (DI: 00062790820015). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

Vivosonic Inc

Evoked-potential audiometer
Primary Device ID00062790870072
NIH Device Record Key81ec1f11-d8c1-4733-960d-197c5e9ca52d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEarDome
Version Model Number100004
Company DUNS201740425
Company NameVivosonic Inc
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100062790870072 [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 Date2019-11-06
Device Publish Date2019-10-29

On-Brand Devices [EarDome]

00062790870072EarDomes (2 pack) for use with Vivosonic Screener (DI: 00062790820015). The UDI is comprised of
00627908070074EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017). The UDI is comprised of

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