BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PROTOZ

    DI: B667PROTOZ1 · Model: 01 · NEXT SIGHT SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PROTOZ
    Primary DI
    B667PROTOZ1
    Version / Model
    01
    Company Name
    NEXT SIGHT SRL
    Labeler DUNS
    437331574
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-09
    Public Version
    1
    Public Version Date
    2019-12-17
    Public Version Status
    New
    Public Device Record Key
    7b9b85c9-4fc4-4231-be0f-63a7b5e71031

    Device Description

    ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent) with different outline colors.

    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
    No
    Has Serial Number
    Yes
    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
    Package B667PROTOZ01
    Primary B667PROTOZ1