BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IsoLED Mini LED HL

    DI: 00816835023967 · Model: IL-2397 · Medical Illumination International Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IsoLED Mini LED HL
    Primary DI
    00816835023967
    Version / Model
    IL-2397
    Company Name
    Medical Illumination International Inc.
    Labeler DUNS
    093357739
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-02
    Public Version
    1
    Public Version Date
    2023-10-10
    Public Version Status
    New
    Public Device Record Key
    d42ae5f9-6a30-4e26-8f72-c4f4847ce54f

    Device Description

    IsoLED mini LEDHL, Attached to Safety Glasses

    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
    HPP Headlamp, Operating, Battery-Operated

    GMDN Terms

    Code Name
    46807 Head-worn lamp

    Identifiers

    Type ID
    Package 01816835023966
    Primary 00816835023967