BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MICOR Vitrector

    DI: 00850005541042 · Model: FG-50829 · Carl Zeiss Meditec, Cataract Technology, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    MICOR Vitrector
    Primary DI
    00850005541042
    Version / Model
    FG-50829
    Company Name
    Carl Zeiss Meditec, Cataract Technology, Inc.
    Labeler DUNS
    080125056
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2023-07-28
    Public Version
    1
    Public Version Date
    2023-08-07
    Public Version Status
    New
    Public Device Record Key
    e5df2f40-2780-4b72-a9fe-752db2e323b7
    Distribution End Date
    2023-07-28

    Device Description

    Ophthalmic Anterior Vitrectomy Device

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    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
    MLZ Vitrectomy, Instrument Cutter

    GMDN Terms

    Code Name
    45071 Phacoemulsification system

    Identifiers

    Type ID
    Primary 00850005541042
    Unit of Use 10850005541049

    Premarket Submissions

    Submission Number Supplement Number
    K200584 000