BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sanibel Supply

    DI: 05711117008395 · Model: Ear tip, OAE-4 ER Infant, 4 mm red flanged · Interacoustics A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Sanibel Supply
    Primary DI
    05711117008395
    Version / Model
    Ear tip, OAE-4 ER Infant, 4 mm red flanged
    Company Name
    Interacoustics A/S
    Labeler DUNS
    306308354
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    2
    Public Version Date
    2025-06-30
    Public Version Status
    Update
    Public Device Record Key
    34b2e52e-9ece-47d6-9db1-f9f1580d62b3

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    ETT Cushion, Earphone (For Audiometric Testing)

    GMDN Terms

    Code Name
    62133 Audiometric ear tip

    Identifiers

    Type ID
    Package 05711117086447
    Primary 05711117008395
    Package 05711117086430
    Package 05711117119060