BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fundus Camera

    DI: 06973211070602 · Model: SK-650A · CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fundus Camera
    Primary DI
    06973211070602
    Version / Model
    SK-650A
    Company Name
    CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
    Labeler DUNS
    545824560
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-02
    Public Version
    1
    Public Version Date
    2020-07-10
    Public Version Status
    New
    Public Device Record Key
    bf2a12e9-b115-4dcc-9a75-a08a9077dff1

    Device Description

    It is an AC-powered device intended to take photographs of the fundus of eye

    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
    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 06973211070602