BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CoolTouch ReNew

    DI: 00859932006037 · Model: R7300-0055 · NEW STAR LASERS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CoolTouch ReNew
    Primary DI
    00859932006037
    Version / Model
    R7300-0055
    Catalog Number
    LC225
    Company Name
    NEW STAR LASERS, INC.
    Labeler DUNS
    877266163
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    3
    Public Version Date
    2020-08-06
    Public Version Status
    Update
    Public Device Record Key
    d401ba1a-b9b3-4c9e-8d3a-87bf2a9f9998
    Distribution End Date
    2018-09-26

    Device Description

    Nd:YAG Laser System

    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    36170 General/multiple surgical solid-state laser system

    Identifiers

    Type ID
    Primary 00859932006037