BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Enova Illumination

    DI: 00850025993463 · Model: 80094 · Enova Illumination, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Enova Illumination
    Primary DI
    00850025993463
    Version / Model
    80094
    Company Name
    Enova Illumination, Inc.
    Labeler DUNS
    080805136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-27
    Public Version
    1
    Public Version Date
    2022-02-04
    Public Version Status
    New
    Public Device Record Key
    b323b8e0-6f3b-4ec3-b52e-7aad6c181cd6

    Device Description

    Qubit Cool/XLT-105A LED Surgical Light

    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
    Yes
    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
    HPP Headlamp, Operating, Battery-Operated

    GMDN Terms

    Code Name
    46807 Head-worn lamp

    Identifiers

    Type ID
    Primary 00850025993463