BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    60MM HANDPIECE W/ACC, TEMPSURE

    DI: 00841494105105 · Model: 100-7027-165 · Cynosure, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    60MM HANDPIECE W/ACC, TEMPSURE
    Primary DI
    00841494105105
    Version / Model
    100-7027-165
    Company Name
    Cynosure, LLC
    Labeler DUNS
    780318028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-16
    Public Version
    3
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    c836c7df-3f7f-4367-ae7f-ccc99d77bbaf

    Device Description

    60MM HANDPIECE W/ACC, TEMPSURE

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI Electrosurgical, cutting & coagulation & accessories
    PBX Massager, vacuum, radio frequency induced heat

    GMDN Terms

    Code Name
    11490 Electrosurgical system generator

    Identifiers

    Type ID
    Primary 00841494105105

    Premarket Submissions

    Submission Number Supplement Number
    K190678 000