Integrity OAE Probe

GUDID 00062790820121

UG OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00062790820015). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).

Vivosonic Inc

Otoacoustic emission system, battery-powered
Primary Device ID00062790820121
NIH Device Record Keye2f7dd3b-e540-423d-9745-db55715846d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegrity OAE Probe
Version Model NumberP81-UG
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100062790820121 [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 Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Integrity OAE Probe ]

00062790820121UG OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00062
00062790820114GP OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00062
00062790810078UG OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00062
00062790810061GP OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00062
00627908020123UG OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00627
00627908020116GP OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00627
00627908010070UG OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627
00627908010063GP OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627

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