BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Orbital LED Mask

    DI: 00858830007061 · Model: RB2015 · PULSADERM LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Orbital LED Mask
    Primary DI
    00858830007061
    Version / Model
    RB2015
    Company Name
    PULSADERM LLC
    Labeler DUNS
    080429881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-04
    Public Version
    2
    Public Version Date
    2020-07-07
    Public Version Status
    Update
    Public Device Record Key
    739c5ca4-6552-4545-a9fb-412dddfe627e

    Device Description

    LED light for the treatment of wrinkles

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OHS Light Based Over The Counter Wrinkle Reduction

    GMDN Terms

    Code Name
    62202 Blue/red/infrared phototherapy lamp

    Identifiers

    Type ID
    Primary 00858830007061