BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FJ2000 System

    DI: 00889795131256 · Model: P65-002-0006 · PARAGON 28, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FJ2000 System
    Primary DI
    00889795131256
    Version / Model
    P65-002-0006
    Catalog Number
    P65-002-0006
    Company Name
    PARAGON 28, INC.
    Labeler DUNS
    042961576
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-25
    Public Version
    1
    Public Version Date
    2023-11-02
    Public Version Status
    New
    Public Device Record Key
    41548d51-41f6-444f-8f37-7f20333fb72c

    Device Description

    FJ-2000, Hardware for Fluid Bag

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HAB SAW, POWERED, AND ACCESSORIES

    GMDN Terms

    Code Name
    41264 Surgical power tool system control unit, line-powered

    Identifiers

    Type ID
    Primary 00889795131256