BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Quest Spectrum Kit for open surgery

    DI: 08719324487030 · Model: ART-ICG-0001 · Quest Projects B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Quest Spectrum Kit for open surgery
    Primary DI
    08719324487030
    Version / Model
    ART-ICG-0001
    Company Name
    Quest Projects B.V.
    Labeler DUNS
    386614502
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-04
    Public Version
    1
    Public Version Date
    2020-03-12
    Public Version Status
    New
    Public Device Record Key
    4f81fe34-4e75-44b5-ab22-e91de2f4b33c

    Device Description

    kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for injection, USP 10ml vial 1x1 piece drape art-drp-0-004

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OWN Confocal Optical Imaging

    GMDN Terms

    Code Name
    57883 Surgical microscope fluorescent angiography system

    Identifiers

    Type ID
    Primary 08719324487030