Unity 4 / Measure 100.310

GUDID 05711781003078

2000-1 Fitting Unit Audiometer

Auditdata A/S

Audiometric/hearing aid tester
Primary Device ID05711781003078
NIH Device Record Key1e29983f-be75-4d4d-9e40-140fec72ab94
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnity 4 / Measure
Version Model NumberFitting Unit Package (2000-1)
Catalog Number100.310
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
GS105711781002682 [Package]
Package: [1 Units]
In Commercial Distribution
GS105711781002699 [Package]
Package: [1 Units]
In Commercial Distribution
GS105711781002705 [Package]
Package: [1 Units]
In Commercial Distribution
GS105711781002712 [Package]
Package: [1 Units]
In Commercial Distribution
GS105711781003078 [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 / Measure]

057117810030782000-1 Fitting Unit Audiometer
057117810028662000-1 Fitting Unit Audiometer
057117810028352000-1 Fitting Unit Audiometer
057117810028282000-1 Fitting Unit Audiometer
057117810028042000-1 Fitting Unit Audiometer
057117810027742000-1 Fitting Unit Audiometer
057117810027362000-1 Fitting Unit Audiometer
057117810027292000-1 Fitting Unit Audiometer
05711781003818UNITY 4 PROBE MIC US PACKAGE

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