BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rexxam

    DI: 04540008320138 · Model: DL-2000 P · REXXAM CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rexxam
    Primary DI
    04540008320138
    Version / Model
    DL-2000 P
    Catalog Number
    ALJ02
    Company Name
    REXXAM CO., LTD.
    Labeler DUNS
    704538487
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-20
    Public Version
    1
    Public Version Date
    2026-04-28
    Public Version Status
    New
    Public Device Record Key
    0fc6a2f9-7a9c-4312-b3f2-6240567cb392

    Device Description

    This device intends to measure vertex powers and prismatic effects of spectacle and contact lenses, to orientate and mark uncut lenses, and to verify the correct mounting of lenses in spectacle frames.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HLM Instrument, Measuring, Lens, Ac-Powered

    GMDN Terms

    Code Name
    12326 Manually-adjusted lensmeter, line-powered

    Identifiers

    Type ID
    Primary 04540008320138