FDA.reportPublic FDA data

Siemens

Primary DI
04047622004197
Brand
Siemens
Company
Ws Audiology Usa, Inc.
Model
UNITY 3 HIT UNIT - REWORKED
Catalog number
10829618
Device description
Siemens UNITY 3 HIT UNIT - REWORKED
Published
2016-05-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047622004197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047622004197040476220041974047622004197

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing aid testerAn electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880288117SIGNIAD&C Charger RIC210518832026-07-16
05714880288124SIGNIAD&C Charger BTE SP210518842026-07-16
05714880288131SIGNIAD&C CHARGER BTE P210518852026-07-16
05714880288148SIGNIAD&C Charger slimRIC210518862026-07-16
05714880288155CONNEXXCharging+ Station B-HP210518882026-07-16
05714880288162CONNEXXCharging+ Station R210518872026-07-16
05714880288179CONNEXXCharging+ Station B-P210518892026-07-16
05714880288186CONNEXXCharging+ Station SR210518902026-07-16
05714880297508SIGNIACHARGER RIC210538802026-07-16
05714880297515CONNEXXCharging Station B-M210538872026-07-16
05714880297522CONNEXXCharging Station R210538862026-07-16
05714880297539CONNEXXCharging Station B-HP210538852026-07-16
05714880297546CONNEXXCharging Station B-P210538842026-07-16
05714880297553SIGNIACHARGER BTE M210538832026-07-16
05714880297560SIGNIACHARGER BTE P210538822026-07-16
05714880297577SIGNIACHARGER BTE SP210538812026-07-16
05714880297928SIGNIAD&C CHARGER BTE P210558932026-07-16
05714880297935SIGNIAD&C Charger BTE SP210558942026-07-16
05714880297942SIGNIAD&C Charger RIC210558952026-07-16
05714880297959SIGNIAD&C Charger slimRIC210558962026-07-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817020021225DD45S (10 Ohms) HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
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00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
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00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
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