BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FIBER, STANDARD, HC, GMPP

    DI: 00817495023243 · Model: 7123-CE-0658 · Candela Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FIBER, STANDARD, HC, GMPP
    Primary DI
    00817495023243
    Version / Model
    7123-CE-0658
    Catalog Number
    7123-CE-0658
    Company Name
    Candela Corporation
    Labeler DUNS
    053468385
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-17
    Public Version
    2
    Public Version Date
    2022-10-12
    Public Version Status
    Update
    Public Device Record Key
    84bb7ab6-b3f6-48d3-8019-22ae8d1daa4d

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    47883 Dermatological solid-state laser system

    Identifiers

    Type ID
    Primary 00817495023243

    Premarket Submissions

    Submission Number Supplement Number
    K201111 000