BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Standard Hand-piece packing Assy, CO2RE

    DI: 00817495024356 · Model: AS85421 · Candela Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Standard Hand-piece packing Assy, CO2RE
    Primary DI
    00817495024356
    Version / Model
    AS85421
    Catalog Number
    AS85421
    Company Name
    Candela Corporation
    Labeler DUNS
    053468385
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-20
    Public Version
    1
    Public Version Date
    2023-10-30
    Public Version Status
    New
    Public Device Record Key
    43a892d3-0793-4992-b426-2d84ea51b5f0

    Device Description

    Standard Hand-piece packing Assy, CO2RE

    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
    No
    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    61473 Dermatological carbon dioxide laser system

    Identifiers

    Type ID
    Primary 00817495024356
    Previous 07290109950754

    Customer Contacts

    Phone
    8007352737
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181523 000