BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Smartlipo Fiber w/ RFID, 600um Fiber, 10 pack

    DI: 10841494100398 · Model: 807-5001-614 · Cynosure, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Smartlipo Fiber w/ RFID, 600um Fiber, 10 pack
    Primary DI
    10841494100398
    Version / Model
    807-5001-614
    Company Name
    Cynosure, LLC
    Labeler DUNS
    780318028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    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
    debb00e2-f81a-42af-a983-3ac2b1c733db

    Device Description

    Smartlipo Fiber w/ RFID, 600um Fiber, 10 pack

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    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 10841494100398
    Unit of Use 00841494100391

    Premarket Submissions

    Submission Number Supplement Number
    K091537 000