BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pelleve S5

    DI: 00841494106706 · Model: IEC5P-ST (MOD2) · Cynosure, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pelleve S5
    Primary DI
    00841494106706
    Version / Model
    IEC5P-ST (MOD2)
    Catalog Number
    IEC5P-ST (MOD2)
    Company Name
    Cynosure, LLC
    Labeler DUNS
    780318028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    4
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    044df122-d8c7-45fe-914b-bdedeb42d1f8

    Device Description

    PELLEVE S5 RF GENERATOR

    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
    GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

    GMDN Terms

    Code Name
    44776 Electrosurgical system

    Identifiers

    Type ID
    Primary 00841494106706