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    FDA UDI In Commercial Distribution 🇺🇸 United States

    S4Optik REF-K2000

    DI: 00860014277528 · Model: REF-K2000 · Lombart Brothers, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    S4Optik REF-K2000
    Primary DI
    00860014277528
    Version / Model
    REF-K2000
    Company Name
    Lombart Brothers, Inc.
    Labeler DUNS
    097420376
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-18
    Public Version
    1
    Public Version Date
    2025-10-27
    Public Version Status
    New
    Public Device Record Key
    4ddbabb8-c84c-4c0f-9943-179cab7c5ed7

    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
    HKO Refractometer, Ophthalmic

    GMDN Terms

    Code Name
    36386 Automated ophthalmic refractometer

    Identifiers

    Type ID
    Primary 00860014277528