BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Isolator Surgical Ablation System

    DI: 00818354010824 · Model: EML2 · ATRICURE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Isolator Surgical Ablation System
    Primary DI
    00818354010824
    Version / Model
    EML2
    Catalog Number
    A000467
    Company Name
    ATRICURE, INC.
    Labeler DUNS
    006133784
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-24
    Public Version
    6
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    a94b83dd-4524-4f99-8f85-aef6f51eac14

    Device Description

    Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

    GMDN Terms

    Code Name
    60784 Cardiac radio-frequency ablation system generator

    Identifiers

    Type ID
    Primary 00818354010824

    Customer Contacts

    Phone
    866-349-2342
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K101174 000