BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Acessa ProVu Dual Foot Pedal

    DI: 00854763006256 · Model: MS-06-0171 · ACESSA HEALTH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Acessa ProVu Dual Foot Pedal
    Primary DI
    00854763006256
    Version / Model
    MS-06-0171
    Company Name
    ACESSA HEALTH INC.
    Labeler DUNS
    080935394
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-07
    Public Version
    1
    Public Version Date
    2020-12-15
    Public Version Status
    New
    Public Device Record Key
    2f704d83-099c-48f8-9399-1b80649fb67c

    Device Description

    Pneumatic foot pedals with tubing used to turn RF energy on and off.

    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
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

    GMDN Terms

    Code Name
    57972 Radio-frequency ablation system

    Identifiers

    Type ID
    Primary 00854763006256

    Premarket Submissions

    Submission Number Supplement Number
    K181124 000