BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PrecistionTx Handpiece, 2 Pack

    DI: 10841494100374 · Model: 100-7019-015 · Cynosure, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    PrecistionTx Handpiece, 2 Pack
    Primary DI
    10841494100374
    Version / Model
    100-7019-015
    Company Name
    Cynosure, LLC
    Labeler DUNS
    780318028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2018-08-22
    Public Version
    2
    Public Version Date
    2023-01-11
    Public Version Status
    Update
    Public Device Record Key
    0b2f4548-9d69-495d-b105-df59a29bf1b2

    Device Description

    PrecistionTx Handpiece, 2 Pack

    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
    No
    Has Lot/Batch Number
    No
    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
    36150 General/multiple surgical frequency-doubled solid-state laser system

    Identifiers

    Type ID
    Primary 10841494100374
    Unit of Use 00841494100377

    Premarket Submissions

    Submission Number Supplement Number
    K121127 000