BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pen LED

    DI: 08033638801048 · Model: Pen LED light · SAPI MED SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Pen LED
    Primary DI
    08033638801048
    Version / Model
    Pen LED light
    Catalog Number
    B.0306
    Company Name
    SAPI MED SPA
    Labeler DUNS
    437320088
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-02
    Public Version
    1
    Public Version Date
    2023-08-10
    Public Version Status
    New
    Public Device Record Key
    180b9d05-2b10-4a8d-873e-18d03353f1d8

    Device Description

    Pen-LED-light for Sapi Med anoscopes, rectoscopes and retractors.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NTN Led Light Source

    GMDN Terms

    Code Name
    35906 Endoscopic light source unit, battery-powered

    Identifiers

    Type ID
    Package 08033638801055
    Primary 08033638801048