BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FLEX Vessel Prep System

    DI: 00863656000318 · Model: FSC 4-40 · Venturemed Group, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FLEX Vessel Prep System
    Primary DI
    00863656000318
    Version / Model
    FSC 4-40
    Catalog Number
    FSC 4-40
    Company Name
    Venturemed Group, Inc.
    Labeler DUNS
    027796091
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-27
    Public Version
    3
    Public Version Date
    2023-04-21
    Public Version Status
    Update
    Public Device Record Key
    a6aecf6b-0842-4a37-8297-1cd8aa9931d6

    Device Description

    FLEX Vessel Prep System, FSC 4-40

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PNO Catheter, Percutaneous, Cutting/Scoring

    GMDN Terms

    Code Name
    44088 Coronary angioplasty balloon catheter, cutting/scoring

    Identifiers

    Type ID
    Primary 00863656000318