BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    truSculpt 16 Hand Held

    DI: 00816722022448 · Model: truSculpt 16 Hand Held · CUTERA, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    truSculpt 16 Hand Held
    Primary DI
    00816722022448
    Version / Model
    truSculpt 16 Hand Held
    Company Name
    CUTERA, INC.
    Labeler DUNS
    041071643
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-27
    Public Version
    1
    Public Version Date
    2018-07-30
    Public Version Status
    New
    Public Device Record Key
    66d856b1-6b84-429b-b05c-64d54e0f40fc

    Device Description

    truSculpt 16 Hand Held RF Handpiece for iD

    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 00816722022448