BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Echolaser Smart Interface (ESI)

    DI: 08052286590173 · Model: EI KT0 0005 521 · ELESTA SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Echolaser Smart Interface (ESI)
    Primary DI
    08052286590173
    Version / Model
    EI KT0 0005 521
    Company Name
    ELESTA SPA
    Labeler DUNS
    895683282
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-19
    Public Version
    1
    Public Version Date
    2021-06-28
    Public Version Status
    New
    Public Device Record Key
    0d93beaa-edf2-4213-abc7-378d2e3e7a7d

    Device Description

    Echolaser Smart Interface (ESI) and its accessories

    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
    Yes
    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
    OUG Medical Device Data System

    GMDN Terms

    Code Name
    64608 Ultrasound-guided laser thermal therapy needle guide positioning system

    Identifiers

    Type ID
    Primary 08052286590173