BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INDIBA DEEP CARE - REVERSO - Tip 88 pins

    DI: 18434251002718 · Model: ACC1015 · INDIBA SA.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INDIBA DEEP CARE - REVERSO - Tip 88 pins
    Primary DI
    18434251002718
    Version / Model
    ACC1015
    Catalog Number
    REVERSO tip 88 pins
    Company Name
    INDIBA SA.
    Labeler DUNS
    460060916
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-05
    Public Version
    2
    Public Version Date
    2023-06-23
    Public Version Status
    Update
    Public Device Record Key
    a8f985e0-1195-4e3a-90f0-ed8389e9d7ee

    Device Description

    Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to be treated in a functional manner.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Dry Heat Sterilization

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    66285 Intradermal radio-frequency ablation system

    Identifiers

    Type ID
    Primary 18434251002718

    Premarket Submissions

    Submission Number Supplement Number
    K212107 000