FDA.reportPublic FDA data

Siemens

Primary DI
04046355641976
Brand
Siemens
Company
Ws Audiology Usa, Inc.
Model
UNITY 3 SOFTWARE (USB STICK)
Catalog number
10823966
Device description
Siemens UNITY 3 SOFTWARE (USB STICK)
Published
2016-05-07
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
04046355641976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046355641976040463556419764046355641976

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
05714880296440SIGNIAKIT Silk C&G 7IX RB210550502026-07-22
05714880296464SIGNIAKIT Silk C&G 7IX RB210550522026-07-22
05714880296488SIGNIAKIT Silk C&G 5IX RB210550542026-07-22
05714880296501SIGNIAKIT Silk C&G 5IX RB210550562026-07-22
05714880296525SIGNIAKIT Silk C&G 3IX RB210550582026-07-22
05714880296549SIGNIAKIT Silk C&G 3IX RB210550602026-07-22
05714880296563SIGNIAKIT Silk C&G 2IX RB210550622026-07-22
05714880296587SIGNIAKIT Silk C&G 2IX RB210550642026-07-22
05714880296600SIGNIAKIT Silk C&G 1IX RB210550662026-07-22
05714880296624SIGNIAKIT Silk C&G 1IX RB210550682026-07-22
05714880296648SIGNIAKIT Silk C&G sDemo DIX RB210550702026-07-22
05714880296679SIGNIAKIT Styletto sDemo DIX RB210551302026-07-22
05714880296709SIGNIAKIT Styletto 1IX RB210551272026-07-22
05714880296716SIGNIAKIT Styletto 1IX RB210551262026-07-22
05714880296747SIGNIAKIT Styletto 2IX RB210551222026-07-22
05714880296754SIGNIAKIT Styletto 2IX RB210551212026-07-22
05714880296853SIGNIAKIT Styletto 3IX RB210551112026-07-22
05714880296860SIGNIAKIT Styletto 3IX RB210551102026-07-22
05714880296877SIGNIAKIT Styletto 3IX RB210551092026-07-22
05714880296884SIGNIAKIT Styletto 3IX RB210551082026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
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00817020021096DD45-300 Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021133OAE Probe OP23INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021218DD450 HF HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021225DD45S (10 Ohms) HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021232DD45S (10 Ohms) Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020020280Capella2 OAE Start-Up KitINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021003B81 Bone VibratorINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021010B81 Bone Vibrator CableINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021171Bone Vibrator Cable for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
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
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23