BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T-SHAPE 2

    DI: 08053782383283 · Model: T-SHAPE 2 · B&M SRL MARKETING NEL BENESSERE
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T-SHAPE 2
    Primary DI
    08053782383283
    Version / Model
    T-SHAPE 2
    Company Name
    B&M SRL MARKETING NEL BENESSERE
    Labeler DUNS
    445139129
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-11
    Public Version
    2
    Public Version Date
    2025-06-30
    Public Version Status
    Update
    Public Device Record Key
    dd6f340f-b7f4-439c-89bb-2a6bc6efe4e2

    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
    NUV Massager, Vacuum, Light Induced Heating
    PBX Massager, Vacuum, Radio Frequency Induced Heat

    GMDN Terms

    Code Name
    44832 Multi-modality skin/body contouring system

    Identifiers

    Type ID
    Primary 08053782383283

    Premarket Submissions

    Submission Number Supplement Number
    K231092 000