BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STARKEY HEARING TECHNOLOGIES

    DI: 00842318168481 · Model: STARKEY HEARING TECHNOLOGIES REMOTE · STARKEY LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STARKEY HEARING TECHNOLOGIES
    Primary DI
    00842318168481
    Version / Model
    STARKEY HEARING TECHNOLOGIES REMOTE
    Catalog Number
    43011-100
    Company Name
    STARKEY LABORATORIES, INC.
    Labeler DUNS
    055461479
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-27
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    b9eb06ed-63b0-4f6f-96f7-82595cd439e1

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    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

    GMDN Terms

    Code Name
    57885 Hearing aid/implant system remote control

    Identifiers

    Type ID
    Primary 00842318168481

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 60 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 95 Percent (%) Relative Humidity