FDA.reportPublic FDA data

Widex

Primary DI
05706069482942
Brand
Widex
Company
Widex A/S
Model
S2-VSD
Catalog number
8 354 0300 068
Device description
Widex SUPER220 S2-VSD BTE, Telecoil, Volume control, RC coil
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110973000IE-ZEN (IN CLEAR SERIES HEARING AID)Widex USA2011-05-05KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05706069482942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05706069482942057060694829425706069482942

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544355600widex@widex.com

Regulatory Flags#

DUNS number
309843613
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880292077WidexALLURE ARRD2 440210488562026-05-22
05714880292084WidexALLURE ARRD2 440210488552026-05-22
05714880292091WidexALLURE ARRD2 440210488542026-05-22
05714880292107WidexALLURE ARRD2 440210488532026-05-22
05714880292114WidexALLURE ARRD2 440210488522026-05-22
05714880292121WidexALLURE ARRD2 440210488512026-05-22
05714880292138WidexALLURE ARRD2 440210488502026-05-22
05714880292145WidexALLURE ARRD2 440210488492026-05-22
05714880292152WidexALLURE ARRD2 440210488482026-05-22
05714880292169WidexALLURE ARRD2 440210488472026-05-22
05714880292176WidexALLURE ARRD2 330210488462026-05-22
05714880292183WidexALLURE ARRD2 330210488452026-05-22
05714880292190WidexALLURE ARRD2 330210488442026-05-22
05714880292206WidexALLURE ARRD2 330210488432026-05-22
05714880292213WidexALLURE ARRD2 330210488422026-05-22
05714880292220WidexALLURE ARRD2 330210488412026-05-22
05714880292237WidexALLURE ARRD2 330210488402026-05-22
05714880292244WidexALLURE ARRD2 330210488392026-05-22
05714880292251WidexALLURE ARRD2 330210488382026-05-22
05714880292268WidexALLURE ARRD2 330210488372026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880296440SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296860SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296877SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296884SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296891SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296907SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296914SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297010SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297027SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297034SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297041SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297058SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297065SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297072SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297188SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297195SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297201SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297218SIGNIAWs Audiology Usa, Inc.KLW2026-07-22