BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sheathes

    DI: 10842418104232 · Model: 35386 · SHEATHING TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    40

    Basic Information

    Brand Name
    Sheathes
    Primary DI
    10842418104232
    Version / Model
    35386
    Company Name
    SHEATHING TECHNOLOGIES, INC.
    Labeler DUNS
    806806220
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    40
    Record Status
    Published
    Publish Date
    2019-07-29
    Public Version
    1
    Public Version Date
    2019-08-06
    Public Version Status
    New
    Public Device Record Key
    c58245ac-2c95-44aa-bb14-52eca8a56aba

    Device Description

    Polyurethane, 3.5"W x 12"L, Non-Sterile, Ultrasound Probe Cover with 1 Elastic, Rolled, Individually Wrapped

    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
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    44713 Body-surface ultrasound imaging transducer cover

    Identifiers

    Type ID
    Package 20842418104239
    Primary 10842418104232
    Unit of Use 00842418104235