BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Omnilux Contour GLOVE

    DI: 05060534510210 · Model: TN19S · I-SMART DEVELOPMENTS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Omnilux Contour GLOVE
    Primary DI
    05060534510210
    Version / Model
    TN19S
    Catalog Number
    125A
    Company Name
    I-SMART DEVELOPMENTS LIMITED
    Labeler DUNS
    223616320
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-05
    Public Version
    2
    Public Version Date
    2023-06-14
    Public Version Status
    Update
    Public Device Record Key
    bde0ef2f-7ec4-4877-94b5-928e3a379fa0

    Device Description

    LED Glove Device- Omnilux Contour Branded

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    ILY Lamp, Infrared, Therapeutic Heating

    GMDN Terms

    Code Name
    65723 Red/infrared light phototherapy unit

    Identifiers

    Type ID
    Primary 05060534510210

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -5 – 55 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    20 – 85 Percent (%) Relative Humidity