BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Acessa Table Top Field Generator

    DI: 00854763006126 · Model: 5200 · ACESSA HEALTH INC.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Acessa Table Top Field Generator
    Primary DI
    00854763006126
    Version / Model
    5200
    Company Name
    ACESSA HEALTH INC.
    Labeler DUNS
    080935394
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-11
    Public Version
    4
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    8b2d1eb9-3cd3-49c5-81ca-27693656dc5a

    Device Description

    Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. Includes TTFG Pad Set

    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
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OEW Tracking, Soft Tissue, Intraoperative
    ITX Transducer, Ultrasonic, Diagnostic
    IYO System, Imaging, Pulsed Echo, Ultrasonic
    HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

    GMDN Terms

    Code Name
    58183 Electromagnetic surgical navigation device tracking system

    Identifiers

    Type ID
    Primary 00854763006126