BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00846430004726 · Model: ER7-14C-500 · ETYMOTIC RESEARCH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    500

    Basic Information

    Brand Name
    N/A
    Primary DI
    00846430004726
    Version / Model
    ER7-14C-500
    Company Name
    ETYMOTIC RESEARCH, INC.
    Labeler DUNS
    115380859
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    500
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    4
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    c5f7c0f3-e0b6-4fb4-88e5-c74643a7b2e1

    Device Description

    Probe Tubes

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

    GMDN Terms

    Code Name
    45241 Audiometric/hearing aid tester

    Identifiers

    Type ID
    Primary 00846430004726
    Unit of Use 00846430005013

    Premarket Submissions

    Submission Number Supplement Number
    K861113 000