BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INFRARED 800 with FLOW® 800 Option

    DI: 04049539102362 · Model: 302581-9245-000 302581-9250-000 302581-9246-000 · Carl Zeiss Meditec AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INFRARED 800 with FLOW® 800 Option
    Primary DI
    04049539102362
    Version / Model
    302581-9245-000 302581-9250-000 302581-9246-000
    Company Name
    Carl Zeiss Meditec AG
    Labeler DUNS
    342228620
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    a6b307eb-6159-4f4f-a628-9242e8712783

    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
    No
    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
    IZI System, X-Ray, Angiographic

    GMDN Terms

    Code Name
    57883 Surgical microscope fluorescent angiography system

    Identifiers

    Type ID
    Primary 04049539102362

    Premarket Submissions

    Submission Number Supplement Number
    K100468 000