BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PHOTONVUE CONTROL BOX

    DI: B475PVUECCB100 · Model: PVUECCB-1.0 · FLUOPTICS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PHOTONVUE CONTROL BOX
    Primary DI
    B475PVUECCB100
    Version / Model
    PVUECCB-1.0
    Company Name
    FLUOPTICS
    Labeler DUNS
    260631677
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-19
    Public Version
    4
    Public Version Date
    2022-02-01
    Public Version Status
    Update
    Public Device Record Key
    2e0be256-ce72-43f2-9232-81b47798ae7a
    Distribution End Date
    2018-08-08

    Device Description

    Control box of PhotonVue system

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OWN Confocal Optical Imaging

    GMDN Terms

    Code Name
    37679 Stationary general-purpose fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary B475PVUECCB100

    Premarket Submissions

    Submission Number Supplement Number
    K132475 000