BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affirm 10mm Tip

    DI: 00841494100506 · Model: 100-7004-910 · Cynosure, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Affirm 10mm Tip
    Primary DI
    00841494100506
    Version / Model
    100-7004-910
    Company Name
    Cynosure, LLC
    Labeler DUNS
    780318028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2023-01-11
    Public Version Status
    Update
    Public Device Record Key
    eb7f290e-25c2-494c-ad4e-03438cc8da8e

    Device Description

    Affirm 10mm Tip

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    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
    GEX Powered laser surgical instrument

    GMDN Terms

    Code Name
    61473 Dermatological carbon dioxide laser system

    Identifiers

    Type ID
    Package 10841494100503
    Primary 00841494100506

    Premarket Submissions

    Submission Number Supplement Number
    K070063 000
    K081424 000
    K101601 000