BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    S4 OPTIK

    DI: 08056098470319 · Model: COBRA · COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    S4 OPTIK
    Primary DI
    08056098470319
    Version / Model
    COBRA
    Catalog Number
    103303A00 V0/S10
    Company Name
    COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
    Labeler DUNS
    432448470
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-13
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    e9804c6c-ea0b-48a2-9063-f78ad8c97489

    Device Description

    COBRA FUNDUS CAMERA

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NFJ System, Image Management, Ophthalmic
    HKI Camera, Ophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 08056098470319

    Premarket Submissions

    Submission Number Supplement Number
    K132987 000