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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sterile Sheath for CONVIVO

    DI: 04049539103413 · Model: 302732-0530-000 · Carl Zeiss Meditec AG
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sterile Sheath for CONVIVO
    Primary DI
    04049539103413
    Version / Model
    302732-0530-000
    Company Name
    Carl Zeiss Meditec AG
    Labeler DUNS
    342228620
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-13
    Public Version
    3
    Public Version Date
    2023-09-25
    Public Version Status
    Update
    Public Device Record Key
    15858337-3164-47ce-8d22-aa62d2403dcc

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    LLZ System, Image Processing, Radiological
    GWG Endoscope, Neurological

    GMDN Terms

    Code Name
    44711 Optical medical device procedural cover

    Identifiers

    Type ID
    Primary 04049539103413
    Package 04049539103420
    Package 04049539103635

    Premarket Submissions

    Submission Number Supplement Number
    K181116 000
    K211156 000