FDA.reportPublic FDA data

Sonic

Primary DI
05711583030630
Brand
Sonic
Company
Sonic Innovations, Inc.
Model
186279
Device description
ET60, KIT 10 85 PB BE ENCHANT 60
Published
2018-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K133308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133308000TINNITUS SOUNDSUPPORTOticon A/S2014-03-18KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711583030630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711583030630057115830306305711583030630

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100hama@oticon.com

Regulatory Flags#

DUNS number
968696919
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711583030265Sonic1861572018-08-20
05711583030289Sonic1861592018-08-20
05711583030296Sonic1861602018-08-20
05711583030319Sonic1861622018-08-20
05711583030425Sonic1862222018-08-20
05711583030449Sonic1862242018-08-20
05711583030456Sonic1862252018-08-20
05711583030470Sonic1862272018-08-20
05711583030586Sonic1862742018-08-20
05711583030609Sonic1862762018-08-20
05711583030616Sonic1862772018-08-20
05711583032740Sonic1920782018-08-20
05711583032764Sonic1920802018-08-20
05711583032771Sonic1920812018-08-20
05711583032795Sonic1920832018-08-20
05711583033204Sonic1921242018-08-20
05711583033228Sonic1921262018-08-20
05711583033235Sonic1921272018-08-20
05711583033259Sonic1921292018-08-20
05711583038216Sonic2147102020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880300116TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300123TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880296181WidexWidex A/SKLW2026-10-30
05714880296198WidexWidex A/SKLW2026-10-30
05714880296204WidexWidex A/SKLW2026-10-30
05714880296211WidexWidex A/SKLW2026-10-30
05714880296228WidexWidex A/SKLW2026-10-30
05714880296235WidexWidex A/SKLW2026-10-30
05714880296242WidexWidex A/SKLW2026-10-30
05714880296259WidexWidex A/SKLW2026-10-30
05714880296266WidexWidex A/SKLW2026-10-30
05714880296273WidexWidex A/SKLW2026-10-30
05714880296280WidexWidex A/SKLW2026-10-30
05714880296297WidexWidex A/SKLW2026-10-30
05714880296303WidexWidex A/SKLW2026-10-30
05714880296310WidexWidex A/SKLW2026-10-30
05714880296327WidexWidex A/SKLW2026-10-30
05714880296334WidexWidex A/SKLW2026-10-30
05714880296341WidexWidex A/SKLW2026-10-30
05714880296358WidexWidex A/SKLW2026-10-30
05714880296365WidexWidex A/SKLW2026-10-30
05714880296372WidexWidex A/SKLW2026-10-30
05714880296389WidexWidex A/SKLW2026-10-30
05714880296396WidexWidex A/SKLW2026-10-30
05714880296402WidexWidex A/SKLW2026-10-30
05714880296419WidexWidex A/SKLW2026-10-30
05714880296426WidexWidex A/SKLW2026-10-30
05714880296433WidexWidex A/SKLW2026-10-30