BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Precision Probe Tubes

    DI: 00864994000343 · Model: U76MBY-40 · PRECISION CAST PLASTIC PARTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    40

    Basic Information

    Brand Name
    Precision Probe Tubes
    Primary DI
    00864994000343
    Version / Model
    U76MBY-40
    Catalog Number
    U76MBY-40
    Company Name
    PRECISION CAST PLASTIC PARTS, INC.
    Labeler DUNS
    123486891
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    40
    Record Status
    Published
    Publish Date
    2019-08-06
    Public Version
    2
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    35fc6d2a-64db-4b8b-b7ff-5b9e1af6bff4

    Device Description

    Probe Tubes for Audiometric Testing

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    45241 Audiometric/hearing aid tester

    Identifiers

    Type ID
    Primary 00864994000343
    Unit of Use 10864994000340