BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TEETH WHITENING KIT

    DI: 00681131430333 · Model: IVUL-06W-V1 · Gurunanda, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TEETH WHITENING KIT
    Primary DI
    00681131430333
    Version / Model
    IVUL-06W-V1
    Company Name
    Gurunanda, LLC
    Labeler DUNS
    079671169
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-27
    Public Version
    1
    Public Version Date
    2023-05-05
    Public Version Status
    New
    Public Device Record Key
    5a375828-fee3-4e57-a6a8-3b056168331e

    Device Description

    LED WHITENING ACCELERATOR LIGHT + WHITENING PENS

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    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
    EEG Heat Source For Bleaching Teeth

    GMDN Terms

    Code Name
    31806 Tooth-bleaching acceleration unit

    Identifiers

    Type ID
    Primary 00681131430333