BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIGITAL MEDICAL SCOPE

    DI: 04987669101087 · Model: DS-20 Control Unit · NIDEK CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIGITAL MEDICAL SCOPE
    Primary DI
    04987669101087
    Version / Model
    DS-20 Control Unit
    Company Name
    NIDEK CO.,LTD.
    Labeler DUNS
    690635461
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-31
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    0b6f091b-0f7e-405c-bd10-d13957c26d78

    Device Description

    NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area. DS-20 consists of control unit and optical lens DS-20F (Digital Eye Fundus Camera).

    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
    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
    PJZ Camera, Ophthalmic, General-Use

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 04987669101087

    Customer Contacts

    Phone
    1-800-223-9044
    Email
    [email protected]