BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Therapy EC (FDA)

    DI: 07898616351127 · Model: 980030032 · DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Therapy EC (FDA)
    Primary DI
    07898616351127
    Version / Model
    980030032
    Catalog Number
    980030032
    Company Name
    DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
    Labeler DUNS
    904563269
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-21
    Public Version
    1
    Public Version Date
    2025-01-29
    Public Version Status
    New
    Public Device Record Key
    941d40ce-9dba-4a83-ae2c-e4d95ad7e060

    Device Description

    Laser system for therapy

    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
    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
    NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

    GMDN Terms

    Code Name
    60409 Musculoskeletal/physical therapy laser, professional

    Identifiers

    Type ID
    Primary 07898616351127

    Premarket Submissions

    Submission Number Supplement Number
    K232813 000