BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FDP Probe

    DI: 00894912002869 · Model: FDP-20 · KOVEN TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FDP Probe
    Primary DI
    00894912002869
    Version / Model
    FDP-20
    Catalog Number
    FDP-20
    Company Name
    KOVEN TECHNOLOGY, INC.
    Labeler DUNS
    069261402
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-17
    Public Version
    5
    Public Version Date
    2023-11-03
    Public Version Status
    Update
    Public Device Record Key
    1d33f175-1ac1-43d8-bbf5-590108cf9ecc
    Distribution End Date
    2018-05-21

    Device Description

    Flat PW Doppler probe, 20 MHz

    Device Characteristics

    Single Use
    No
    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
    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
    No

    Product Codes

    Code Name
    JAF Monitor, Ultrasonic, Nonfetal
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    36970 Noninvasive vascular ultrasound system probe

    Identifiers

    Type ID
    Primary 00894912002869

    Customer Contacts

    Phone
    314-542-2101
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K935994 000