BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Insera S5-10 NW O

    DI: 07613389813869 · Model: N/A · Sonova AG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Insera S5-10 NW O
    Primary DI
    07613389813869
    Version / Model
    N/A
    Catalog Number
    063-6399-01
    Company Name
    Sonova AG
    Labeler DUNS
    480662550
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-19
    Public Version
    1
    Public Version Date
    2025-12-29
    Public Version Status
    New
    Public Device Record Key
    53f78edd-3421-4a03-b5c1-bdbf39b169dd

    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
    34672 Air-conduction hearing aid, in-the-ear

    Identifiers

    Type ID
    Primary 07613389813869