BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GN Otometrics A/S

    DI: 05713315003530 · Model: 1012, Ear Tip Kit, 7mm, 50 pcs · NATUS MANUFACTURING LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GN Otometrics A/S
    Primary DI
    05713315003530
    Version / Model
    1012, Ear Tip Kit, 7mm, 50 pcs
    Catalog Number
    8-68-31504
    Company Name
    NATUS MANUFACTURING LIMITED
    Labeler DUNS
    896421240
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-31
    Public Version
    3
    Public Version Date
    2022-12-05
    Public Version Status
    Update
    Public Device Record Key
    5c7ea5f1-a0fc-47ba-ab68-bb6340a5a498

    Device Description

    Silicone Eartip, 7mm, semi red, mushroom

    Device Characteristics

    Single Use
    Yes
    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
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ETY Tester, Auditory Impedance
    ETT Cushion, Earphone (For Audiometric Testing)

    GMDN Terms

    Code Name
    36717 Impedance audiometer

    Identifiers

    Type ID
    Primary 05713315003530