BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ENDOCAVITARY TRANSDUCER

    DI: 04987670004292 · Model: PVL-715RST · CANON MEDICAL SYSTEMS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ENDOCAVITARY TRANSDUCER
    Primary DI
    04987670004292
    Version / Model
    PVL-715RST
    Company Name
    CANON MEDICAL SYSTEMS CORPORATION
    Labeler DUNS
    690575113
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    fce98ccb-95e1-48ef-8d4c-5a4af11f775b

    Device Description

    ENDOCAVITARY TRANSDUCER

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Hydrogen Peroxide

    Product Codes

    Code Name
    ITX Transducer, ultrasonic, diagnostic

    GMDN Terms

    Code Name
    40772 Rectal ultrasound imaging system transducer

    Identifiers

    Type ID
    Primary 04987670004292

    Customer Contacts

    Phone
    +1-8004211968
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K151451 000