BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CIRRUS HD-OCT

    DI: 04057748087141 · Model: 6000 · Carl Zeiss Meditec, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CIRRUS HD-OCT
    Primary DI
    04057748087141
    Version / Model
    6000
    Company Name
    Carl Zeiss Meditec, Inc.
    Labeler DUNS
    362747011
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-01
    Public Version
    2
    Public Version Date
    2020-06-05
    Public Version Status
    Update
    Public Device Record Key
    dbae982e-d19d-44e1-8b1c-857a398c99f1

    Device Description

    The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures.

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OBO Tomography, Optical Coherence

    GMDN Terms

    Code Name
    58850 Ophthalmic spectral-domain optical coherence tomography system

    Identifiers

    Type ID
    Primary 04057748087141