BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CADENCE

    DI: B857000 · Model: 100 · Retina-Ai Health, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CADENCE
    Primary DI
    B857000
    Version / Model
    100
    Company Name
    Retina-Ai Health, Inc.
    Labeler DUNS
    117424067
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-24
    Public Version
    1
    Public Version Date
    2020-03-03
    Public Version Status
    New
    Public Device Record Key
    f659a4d5-8ba2-4f25-8e41-c73621d100b5

    Device Description

    Camera, Ophthalmic, ac-powered

    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
    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
    HKI Camera, Ophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary B857000

    Premarket Submissions

    Submission Number Supplement Number
    K182199 000