FDA.report

Siemens

Primary DI
57117810000743
Brand
Siemens
Company
SIVANTOS, INC.
Model
UNITY 3 WITH INSERTS
Catalog number
10824331
Device description
Siemens UNITY 3 WITH INSERTS
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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EWOAudiometer

Product Code Classifications

CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
57117810000743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5711781000074357117810000743

GMDN Terms

TermDefinition
Audiometric/hearing aid testerAn electroacoustic device intended to be used for the evaluation of hearing loss (audiometer function), the evaluation of hearing aids while worn to assure optimal amplification (real-ear measurement), and/or for other hearing aid analysis (functions as the hearing aid analyser to check its proper function when this is being fitted to the patient). It typically consists of a test box and a control unit that connect to a computer that runs application software to provide results and graphics (which may be stored in a database). The control unit may also be connected to other manufacturer's test boxes, or run as an audiometer or real-ear-measurement instrument without the test box.

Sterilization Methods

Method

Contacts

PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags

DUNS number
157412271
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05714880182743SonyCRE-C10210222962022-09-12
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05714880148671SigniaINSIO 5AX C&G210111452022-08-30
05714880148688SigniaINSIO 7AX C&G210111462022-08-30
05714880175882SigniaINSIO 1AX C&G210111422022-08-30
05714880175899SigniaINSIO 2AX C&G210111432022-08-30
05714880111224SigniaACC. SET STREAMLINE TV US109448242020-10-02
04025515213611SiemensHA PHOENIX 213 BG071670962016-05-05
04025515213758SiemensHA INFINITI PRO S BG087715732016-05-05
04025515218456SiemensHA INTUIS S DIR BG101720292016-05-05
04025515218463SiemensHA INTUIS S DIR GNT101720532016-05-05
04025515218470SiemensHA INTUIS S DIR BLK101720552016-05-05
04025515218487SiemensHA INTUIS DIR BG101474172016-05-05
04025515218494SiemensHA INTUIS DIR GNT101721712016-05-05
04025515218500SiemensHA INTUIS DIR BLK101721732016-05-05
04025515218517SiemensHA INTUIS SP DIR BG101473852016-05-02
04025515218524SiemensHA INTUIS SP DIR GNT101720632016-05-02
04025515218531SiemensHA INTUIS SP DIR BLK101720652016-05-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245103Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245110Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245127Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
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04260223147487nanoAudio DD65v2 Set with Patient Response ButtonPATH medical GmbHEWO2025-08-05
04260223147494nanoAudio DD65v2 Set with Patient Response Button and Hughson-WestlakePATH medical GmbHEWO2025-08-05