BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sublative RF applicator

    DI: 00817495025100 · Model: FG70541 · Candela Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sublative RF applicator
    Primary DI
    00817495025100
    Version / Model
    FG70541
    Catalog Number
    FG70541
    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
    92e83914-634c-4e7a-92e8-0de6f30fd6cc

    Device Description

    Sublative RF Appl.,Pkgd, eMatrix/eTwo/elos Plus

    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    45220 Multi-modality skin surface treatment system

    Identifiers

    Type ID
    Primary 00817495025100
    Previous 07290109950709

    Customer Contacts

    Phone
    8007352737
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K141507 000