FDA.reportPublic FDA data

HANSATON

Primary DI
07613389127225
Brand
HANSATON
Company
Hansaton Akustik GmbH
Model
088-5003
Catalog number
088-5003
Device description
HANSATON Stream Remote App
Published
2019-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389127225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389127225076133891272257613389127225

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49402980110info@hansaton.de

Regulatory Flags#

DUNS number
316040146
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613389143225HANSATON058-5226058-52262018-12-10
07613389143232HANSATON058-5227058-52272018-12-10
04250185527595Hansaton71889718892016-09-23
04250185527601Hansaton71890718902016-09-23
04250185527618Hansaton71891718912016-09-23
04250185527625Hansaton71892718922016-09-23
04250185527632Hansaton71893718932016-09-23
04250185527656Hansaton71895718952016-09-23
04250185527670Hansaton71897718972016-09-23
04250185527687Hansaton71898718982016-09-23
04250185527694Hansaton71899718992016-09-23
04250185527700Hansaton71900719002016-09-23
04250185527717Hansaton71901719012016-09-23
04250185527731Hansaton71903719032016-09-23
04250185527755Hansaton71905719052016-09-23
04250185527762Hansaton71906719062016-09-23
04250185527779Hansaton71907719072016-09-23
04250185527786Hansaton71908719082016-09-23
04250185527793Hansaton71909719092016-09-23
04250185527816Hansaton71911719112016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880279566SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880279573SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880293470SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880293487SigniaWs Audiology Usa, Inc.OSM2026-05-27
07613275596814PhonakSonova AGOSM2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601402PhonakSonova AGOSM2018-02-28
07613275601426PhonakSonova AGOSM2018-02-28
07613275601501PhonakSonova AGOSM2018-02-28
07613275601518PhonakSonova AGOSM2018-02-28
07613275601556PhonakSonova AGOSM2018-02-28
07613275601594PhonakSonova AGOSM2018-02-28
07613275601600PhonakSonova AGOSM2018-02-28
07613275601655PhonakSonova AGOSM2018-02-28
07613275601662PhonakSonova AGOSM2018-02-28
07613275601686PhonakSonova AGOSM2018-02-28
07613275601693PhonakSonova AGOSM2018-02-28
07613275602935PhonakSonova AGOSM2018-02-28
07613275602959PhonakSonova AGOSM2018-02-28