BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    truSculpt 5 RF handpiece

    DI: 00816722022486 · Model: truSculpt 5 RF handpiece · CUTERA, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    truSculpt 5 RF handpiece
    Primary DI
    00816722022486
    Version / Model
    truSculpt 5 RF handpiece
    Company Name
    CUTERA, INC.
    Labeler DUNS
    041071643
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-14
    Public Version
    1
    Public Version Date
    2022-11-22
    Public Version Status
    New
    Public Device Record Key
    42ffa416-8366-47e3-a26b-b0c5c46f9672

    Device Description

    truSculpt 4.5 cm^2 handheld handpiece for use with truSculpt iD RF device

    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
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories
    PBX Massager, Vacuum, Radio Frequency Induced Heat

    GMDN Terms

    Code Name
    45214 Radio-frequency skin contouring system applicator, monopolar

    Identifiers

    Type ID
    Primary 00816722022486