BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Human Tecar

    DI: 08056182720986 · Model: RES electrode Ø 90 mm · UNIBELL SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Human Tecar
    Primary DI
    08056182720986
    Version / Model
    RES electrode Ø 90 mm
    Catalog Number
    16474
    Company Name
    UNIBELL SRL
    Labeler DUNS
    338736462
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-15
    Public Version
    1
    Public Version Date
    2019-06-24
    Public Version Status
    New
    Public Device Record Key
    85898895-c2bd-43b6-94ba-522b2ecbc980

    Device Description

    Low-impedance RES electrode Ø 90 mm

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    PBX Massager, Vacuum, Radio Frequency Induced Heat

    GMDN Terms

    Code Name
    47575 Medium-wave diathermy treatment system

    Identifiers

    Type ID
    Primary 08056182720986

    Premarket Submissions

    Submission Number Supplement Number
    K181211 000