FDA.reportPublic FDA data

Siemens

Primary DI
05711781000004
Brand
Siemens
Company
SIVANTOS, INC.
Model
UNITY 3 REM PROBE ASSEMBLY
Catalog number
10823933
Device description
Siemens UNITY 3 REM PROBE ASSEMBLY
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

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
05711781000004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711781000004057117810000045711781000004

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711781000003SiemensUNITY 3 INSERTS108239362016-05-07
05711781000009SiemensUNITY 3 CLIENT RESPONSE108239422016-05-07
05711781000010SiemensUNITY 3 DD45108239352016-05-07
05711781000012SiemensUNITY 3 3A INSERTS108239342016-05-07
05711781000017SiemensUNITY 3 SOUNDBOOTH CABLE SET108239462016-05-07
05711781000018SiemensUNITY 3 EAR HANGER108239432016-05-07
05711781000020SiemensUNITY 3 DC ADAPTOR (AUD/REM)108239442016-05-07
05711781000021SiemensUNITY 3 USB CABLE FOR PC108240872016-05-07
05711781000024SiemensUNITY 3 MICROPHONE108239412016-05-07
05711781000025SiemensUNITY 3 FREE FIELD SPEAKER108240862016-05-07
05711781000027SiemensUNITY 3 USB ISOLATION CORD108239392016-05-07
05711781000031SiemensUNITY 3 INSERT TUBE W NIPPLES108239562016-05-07
05711781000033SiemensUNITY 3 PROBE TUBE GUIDE108239572016-05-07
05711781000034SiemensUNITY 3 PROBE TUBE108239582016-05-07
05711781000036SiemensUNITY 3 COUPLER MICROPHONE108239512016-05-07
05711781000037SiemensUNITY 3 REFERENCE MICROPHONE108239522016-05-07
05711781000038SiemensUNITY 3 BATTERY PILLS (5 SIZES)108239622016-05-07
05711781000041SiemensUNITY 3 ITE COUPLER ATTACHMENT108239482016-05-07
05711781000042SiemensUNITY 3 BTE COUPLER ATTACHMENT108239492016-05-07
05711781000043SiemensUNITY 3 BODY COUPLER ATTACHMEN108239502016-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
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
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
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
04260223147326nanoAudio DD45PATH medical GmbHEWO2025-08-05
04260223147333nanoAudio DD65v2PATH medical GmbHEWO2025-08-05
04260223147340nanoAudio Patient Response ButtonPATH medical GmbHEWO2025-08-05