FDA.reportPublic FDA data

Siemens

Primary DI
05711781000047
Brand
Siemens
Company
SIVANTOS, INC.
Model
UNITY 3 BTE FOAM
Catalog number
10824089
Device description
Siemens UNITY 3 BTE FOAM
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
05711781000047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711781000047057117810000475711781000047

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
05711781000004SiemensUNITY 3 REM PROBE ASSEMBLY108239332016-05-07
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

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Primary DI, Brand, Company table
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04260223147661Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHEWO2026-07-24
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007511066 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
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