BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sonite R Kit Binaural US

    DI: 07613389804164 · Model: (beige) · Sonova AG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sonite R Kit Binaural US
    Primary DI
    07613389804164
    Version / Model
    (beige)
    Catalog Number
    051-0231-H056
    Company Name
    Sonova AG
    Labeler DUNS
    480662550
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-20
    Public Version
    1
    Public Version Date
    2025-03-28
    Public Version Status
    New
    Public Device Record Key
    22791390-92de-46ef-9914-aac0c7ca4b1e

    Device Description

    Sonite R Kit Binaural US (beige) - Primary DI number: 07613389804164 2 x Sennheiser Sonite R (beige) - Primary DI number: 07613389803990 and 1 x Sennheiser S Charger R - Primary DI number: 07613389738643

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription
    KLW Masker, Tinnitus

    GMDN Terms

    Code Name
    47169 Air-conduction hearing aid, receiver-in-canal

    Identifiers

    Type ID
    Primary 07613389804164