BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KBL 8000 alpha extraSun

    DI: 04260489020111 · Model: KBL 7908 - 50p6/4g 1616 int us (T) · KBL GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KBL 8000 alpha extraSun
    Primary DI
    04260489020111
    Version / Model
    KBL 7908 - 50p6/4g 1616 int us (T)
    Company Name
    KBL GmbH
    Labeler DUNS
    341936227
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-23
    Public Version
    1
    Public Version Date
    2018-11-23
    Public Version Status
    New
    Public Device Record Key
    fa5712d6-9602-47a3-8678-91990870939b

    Device Description

    This device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.

    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
    No
    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
    LEJ Booth, Sun Tan

    GMDN Terms

    Code Name
    46387 Ultraviolet tanning device

    Identifiers

    Type ID
    Primary 04260489020111

    Premarket Submissions

    Submission Number Supplement Number
    K151962 000