BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Hygienic Hand Piece, external, Packaged, CO2RE Intima

    DI: 07290109952406 · Model: AS90245US · SYNERON MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hygienic Hand Piece, external, Packaged, CO2RE Intima
    Primary DI
    07290109952406
    Version / Model
    AS90245US
    Catalog Number
    AS90245US
    Company Name
    SYNERON MEDICAL LTD
    Labeler DUNS
    532685716
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-27
    Public Version
    7
    Public Version Date
    2023-10-17
    Public Version Status
    Update
    Public Device Record Key
    b2fa1256-b2ae-47e6-b530-58587a6d7ab6
    Distribution End Date
    2023-10-16

    Device Description

    Hygienic Hand Piece, external, Packaged, CO2RE Intima

    Device Characteristics

    Single Use
    Yes
    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
    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    61473 Dermatological carbon dioxide laser system

    Identifiers

    Type ID
    Package 17290109952403
    Primary 07290109952406

    Premarket Submissions

    Submission Number Supplement Number
    K181523 000