BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Synergy™ Ablation System

    DI: 00818354010312 · Model: ASU · ATRICURE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Synergy™ Ablation System
    Primary DI
    00818354010312
    Version / Model
    ASU
    Catalog Number
    A000049
    Company Name
    ATRICURE, INC.
    Labeler DUNS
    006133784
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-31
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    0e8bae34-d514-4256-b190-aa21a70dc7b4

    Device Description

    Footswitch ASU2/ASU3

    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
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    GMDN Terms

    Code Name
    60784 Cardiac radio-frequency ablation system generator

    Identifiers

    Type ID
    Primary 00818354010312

    Customer Contacts

    Phone
    866-349-2342
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -35 – 54 Degrees Celsius