FDA.report

Hansaton

Primary DI
04250185545131
Brand
Hansaton
Company
Hansaton Akustik GmbH
Model
050-5608-U846
Catalog number
050-5608-U846
Device description
jam 3-13 P (sparkling bronze)
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250185545131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250185545131042501855451314250185545131

GMDN Terms

TermDefinition
Behind-the-ear air-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods

Method

Contacts

PhoneEmail
+49402980110support@hansaton.com

Regulatory Flags

DUNS number
316040146
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
04250185560462Hansaton075-5841075-58412019-04-12
04250185560479Hansaton075-5841-11075-5841-112019-04-12
04250185543007Hansaton89345893452016-09-23
04250185543014Hansaton89346893462016-09-23
04250185543021Hansaton89347893472016-09-23
04250185558216HANSATON075-5002075-50022018-12-10
04250185558223HANSATON075-5003075-50032018-12-10
04250185558230Hansaton071-5001071-50012016-09-23
07613389088717HANSATON075-5102-11075-5102-112018-12-10
07613389088731HANSATON075-5103-11075-5103-112018-12-10
07613389088755HANSATON075-5107-11075-5107-112018-12-10
07613389088779HANSATON075-5108-11075-5108-112018-12-10
04250185560493Hansaton050-6180-U3050-6180-U32019-03-19
04250185560509Hansaton050-6181-U3050-6181-U32019-03-19
04250185560516Hansaton050-6182-U3050-6182-U32019-03-19
04250185560523Hansaton050-6183-U3050-6183-U32019-03-19
04250185560530Hansaton050-6184-U4050-6184-U42019-03-19
04250185560547Hansaton050-6185-U3050-6185-U32019-03-19
04250185560554Hansaton050-6186-U3050-6186-U32019-03-19
04250185560561Hansaton050-6187-U3050-6187-U32019-03-19

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