BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sanibel Supply A/S

    DI: 05711117244335 · Model: Sanibel REM Probe Tubes, type A · Interacoustics A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Sanibel Supply A/S
    Primary DI
    05711117244335
    Version / Model
    Sanibel REM Probe Tubes, type A
    Company Name
    Interacoustics A/S
    Labeler DUNS
    306308354
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2024-10-07
    Public Version
    1
    Public Version Date
    2024-10-15
    Public Version Status
    New
    Public Device Record Key
    ec976018-98d5-46a6-84df-0a2c5a52226e

    Device Description

    Black, sample kit. Accessory for Real Ear Measurement (REM)

    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
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

    GMDN Terms

    Code Name
    66691 Audiometric/hearing aid tester support kit

    Identifiers

    Type ID
    Unit of Use 05711117228458
    Primary 05711117244335