BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Sculpt I.Q.

    DI: D74666591921 · Model: 6659192 · RAINTREE ESSIX INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    Sculpt I.Q.
    Primary DI
    D74666591921
    Version / Model
    6659192
    Catalog Number
    6659192
    Company Name
    RAINTREE ESSIX INC.
    Labeler DUNS
    801157132
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2018-03-14
    Public Version
    3
    Public Version Date
    2018-11-08
    Public Version Status
    Update
    Public Device Record Key
    6e007e9e-9a20-419f-a9a4-855ade8fadcf
    Distribution End Date
    2018-04-09

    Device Description

    Optic protection cap for handpiece (5 pieces)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    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
    GEX Powered laser surgical instrument
    ILY Lamp, infrared, therapeutic heating

    GMDN Terms

    Code Name
    60340 Dental diode laser system

    Identifiers

    Type ID
    Primary D74666591921
    Unit of Use D74666591920

    Customer Contacts

    Phone
    +1(800)883-8733
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K170500 000