BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CIRRUS photo

    DI: 04049471096026 · Model: CIRRUS photo 800 · Carl Zeiss Meditec AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CIRRUS photo
    Primary DI
    04049471096026
    Version / Model
    CIRRUS photo 800
    Company Name
    Carl Zeiss Meditec AG
    Labeler DUNS
    314594680
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-17
    Public Version
    3
    Public Version Date
    2020-06-05
    Public Version Status
    Update
    Public Device Record Key
    f3192e6b-f466-484a-93a0-e9857415d3d6

    Device Description

    The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.

    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
    Yes
    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
    HKI Camera, Ophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    58850 Ophthalmic spectral-domain optical coherence tomography system
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 04049471096026

    Device Sizes

    Type Value Unit Text
    Weight 33 Kilogram
    Device Size Text, specify Total height (including head rest) 1390 mm (plus 300 mm lift)
    Device Size Text, specify Footprint of table-top unit 469 mm x 466 mm (including lateral cable covers)
    Device Size Text, specify Utility space of instrument table (W x D) 1060 mm x 420 mm

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    10 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 55 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 35 Degrees Celsius