BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Otoscan

    DI: 05713315011054 · Model: 043244 · Natus Medical Denmark ApS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Otoscan
    Primary DI
    05713315011054
    Version / Model
    043244
    Catalog Number
    043244
    Company Name
    Natus Medical Denmark ApS
    Labeler DUNS
    306633756
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-15
    Public Version
    3
    Public Version Date
    2025-10-30
    Public Version Status
    Update
    Public Device Record Key
    6ac57cc5-0957-4292-bb46-6811654b76b3

    Device Description

    1093,OTOSCAN Yearly – Scanner & Headset without laptop, yearly Otocloud subscription

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    ERA Otoscope

    GMDN Terms

    Code Name
    63263 Auditory canal scanner

    Identifiers

    Type ID
    Primary 05713315011054