FDA.reportPublic FDA data

SIGNIA

Primary DI
05714880224689
Brand
SIGNIA
Company
Ws Audiology Usa, Inc.
Model
Active Pro IX
Catalog number
21021812
Device description
S_ITE ACTIVE PRO IX L S SNW
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880224689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880224689057148802246895714880224689

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880288629WSAPortable Charger RIC v1210488982026-11-04
05714880294392CONNEXXIF ITC Travel Charger210545152026-11-04
05714880297416WSAPortable Charger RIC v1210553472026-11-04
05714880297881CONNEXXIF ITC Travel Charger210558872026-11-04
05714880300390WSAPortable Charger RIC v1210567142026-11-04
05714880300116TRUHEARINGTH Premium 7 IF ITC LI210565572026-11-02
05714880300123TRUHEARINGTH Premium 7 IF ITC LI210565582026-11-02
05714880300130TRUHEARINGTH Advanced 7 IF ITC LI210565602026-11-02
05714880300147TRUHEARINGTH Advanced 7 IF ITC LI210565592026-11-02
05714880299359AudioServiceIF ITC Li 8.12210564072026-10-28
05714880299403AudioServiceIF ITC Li 8.12210564202026-10-28
05714880299410AudioServiceIF ITC Li 8.12210564192026-10-28
05714880299427AudioServiceIF ITC Li 8.12210564082026-10-28
05714880299564REXTONReach IF ITC-Li BT 80210564602026-10-28
05714880299571REXTONReach IF ITC-Li BT 80210564622026-10-28
05714880299588REXTONReach IF ITC-Li BT 80210564632026-10-28
05714880299595REXTONReach IF ITC-Li BT 80210564652026-10-28
05714880299601REXTONReach IF ITC-Li BT 60210564682026-10-28
05714880299618REXTONReach IF ITC-Li BT 60210564692026-10-28
05714880299625REXTONReach IF ITC-Li BT 60210564702026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880288629WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880294392CONNEXXWs Audiology Usa, Inc.OSM2026-11-04
05714880297416WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880297881CONNEXXWs Audiology Usa, Inc.OSM2026-11-04
05714880300390WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880300116TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300116TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300123TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300123TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880296181WidexWidex A/SKLW2026-10-30
05714880296181WidexWidex A/SOSM2026-10-30
05714880296198WidexWidex A/SKLW2026-10-30
05714880296198WidexWidex A/SOSM2026-10-30
05714880296204WidexWidex A/SKLW2026-10-30
05714880296204WidexWidex A/SOSM2026-10-30
05714880296211WidexWidex A/SKLW2026-10-30
05714880296211WidexWidex A/SOSM2026-10-30
05714880296228WidexWidex A/SKLW2026-10-30
05714880296228WidexWidex A/SOSM2026-10-30
05714880296235WidexWidex A/SKLW2026-10-30
05714880296235WidexWidex A/SOSM2026-10-30
05714880296242WidexWidex A/SKLW2026-10-30
05714880296242WidexWidex A/SOSM2026-10-30
05714880296259WidexWidex A/SKLW2026-10-30
05714880296259WidexWidex A/SOSM2026-10-30
05714880296266WidexWidex A/SKLW2026-10-30