BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    D-EYE

    DI: 08053369320137 · Model: DEI0300W1S1400 · D-EYE SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    D-EYE
    Primary DI
    08053369320137
    Version / Model
    DEI0300W1S1400
    Company Name
    D-EYE SRL
    Labeler DUNS
    435711752
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-30
    Public Version
    4
    Public Version Date
    2021-05-10
    Public Version Status
    Update
    Public Device Record Key
    2fd9ea09-5b2e-4ed5-a969-6afe76d1ee3b

    Device Description

    D-EYE for iPhone 6+/6S+

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PJZ Camera, Ophthalmic, General-Use

    GMDN Terms

    Code Name
    46786 Direct ophthalmoscope

    Identifiers

    Type ID
    Primary 08053369320137