FDA.reportPublic FDA data

Siemens

Primary DI
04046355364745
Brand
Siemens
Company
Ws Audiology Usa, Inc.
Model
UNITY 2 INSITU HEADBAND SMALL
Catalog number
10603504
Device description
Siemens UNITY 2 INSITU HEADBAND SMALL
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
04046355364745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046355364745040463553647454046355364745

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
05714880299359AudioServiceIF ITC Li 8.12210564072026-10-28
05714880299403AudioServiceIF ITC Li 8.12210564202026-10-28
05714880299410AudioServiceIF ITC Li 8.12210564192026-10-28
05714880299427AudioServiceIF ITC Li 8.12210564082026-10-28
05714880299564REXTONReach IF ITC-Li BT 80210564602026-10-28
05714880299571REXTONReach IF ITC-Li BT 80210564622026-10-28
05714880299588REXTONReach IF ITC-Li BT 80210564632026-10-28
05714880299595REXTONReach IF ITC-Li BT 80210564652026-10-28
05714880299601REXTONReach IF ITC-Li BT 60210564682026-10-28
05714880299618REXTONReach IF ITC-Li BT 60210564692026-10-28
05714880299625REXTONReach IF ITC-Li BT 60210564702026-10-28
05714880299632REXTONReach IF ITC-Li BT 60210564712026-10-28
05714880299649REXTONReach IF ITC-Li BT 40210564722026-10-28
05714880299656REXTONReach IF ITC-Li BT 40210564732026-10-28
05714880299663REXTONReach IF ITC-Li BT 40210564742026-10-28
05714880299670REXTONReach IF ITC-Li BT 40210564752026-10-28
05714880299687REXTONReach IF ITC-Li BT SDemo210564762026-10-28
05714880299694REXTONReach IF ITC-Li BT SDemo210564772026-10-28
05714880299991MIRACLE EARMEMINI I 5 5w ITC-R STD210565402026-10-27
05714880300000MIRACLE EARMEMINI I 5 5w ITC-R STD210565412026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04262406074207MaicoMAICO Diagnostics GmbHEWO2026-09-29
G860TELEDX0TELE-DXHear.com LLCEWO2026-09-25
05711117244540InteracousticsInteracoustics A/SEWO2026-07-28
05711117244557InteracousticsInteracoustics A/SEWO2026-07-28
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04260223147975PIEP (2x2)PATH medical GmbHEWO2026-07-24
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
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057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
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