BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sanibel Supply A/S

    DI: 05711117230482 · Model: Foam ear tip 13 mm, ER1/ER2 · Interacoustics A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    Sanibel Supply A/S
    Primary DI
    05711117230482
    Version / Model
    Foam ear tip 13 mm, ER1/ER2
    Catalog Number
    8536777
    Company Name
    Interacoustics A/S
    Labeler DUNS
    306308354
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2025-04-30
    Public Version
    1
    Public Version Date
    2025-05-08
    Public Version Status
    New
    Public Device Record Key
    b2d74958-20e3-44b4-a9df-45f4198351d5

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    EWO Audiometer

    GMDN Terms

    Code Name
    66677 Vestibulo-auditory analysis system support kit¿

    Identifiers

    Type ID
    Unit of Use 05711117244151
    Primary 05711117230482

    Premarket Submissions

    Submission Number Supplement Number
    K930553 000