BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BLUE 400

    DI: 04049539104342 · Model: 302581-9050-000 · Carl Zeiss Meditec AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    BLUE 400
    Primary DI
    04049539104342
    Version / Model
    302581-9050-000
    Company Name
    Carl Zeiss Meditec AG
    Labeler DUNS
    342228620
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-16
    Public Version
    4
    Public Version Date
    2019-11-21
    Public Version Status
    Update
    Public Device Record Key
    fe2b1cab-178f-4fa6-b8a3-cb679149d082

    Device Description

    for OPMI PENTERO 800 and OPMI PENTERO 900

    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
    Yes
    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
    FSO Microscope, Surgical, General & Plastic Surgery

    GMDN Terms

    Code Name
    41895 Neurosurgical microscope

    Identifiers

    Type ID
    Primary 04049539104342