BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Penlight

    DI: 00786511240875 · Model: S214-ROY · RASHMAN CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Penlight
    Primary DI
    00786511240875
    Version / Model
    S214-ROY
    Company Name
    RASHMAN CORPORATION
    Labeler DUNS
    078803608
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-02
    Public Version
    2
    Public Version Date
    2023-05-03
    Public Version Status
    Update
    Public Device Record Key
    047a93aa-0a0e-4fcf-9838-57201def5376

    Device Description

    Soft LED Pupil Gauge Penlight

    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
    No
    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
    KYT Light, Examination, Medical, Battery Powered

    GMDN Terms

    Code Name
    61754 Vascular implant detacher, electronic, reusable

    Identifiers

    Type ID
    Primary 00786511240875