Unity 4 21031181

GUDID 00571178100316

2000-1 Fitting Unit Audiometer

Auditdata A/S

Audiometric/hearing aid tester
Primary Device ID00571178100316
NIH Device Record Key14cb71b7-49da-4066-a04e-94a56eeae461
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnity 4
Version Model NumberUnity 4 INSITU Package
Catalog Number21031181
Company DUNS310385849
Company NameAuditdata A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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
GS100571178100316 [Primary]

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-29
Device Publish Date2024-08-21

On-Brand Devices [Unity 4]

057117810027502000-1 Fitting Unit Audiometer
005711781003162000-1 Fitting Unit Audiometer

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