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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monster Screw System

    DI: 00889795049940 · Model: P20-060-WD00 · PARAGON 28, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monster Screw System
    Primary DI
    00889795049940
    Version / Model
    P20-060-WD00
    Catalog Number
    P20-060-WD00
    Company Name
    PARAGON 28, INC.
    Labeler DUNS
    042961576
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-17
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    bcaca5bb-4a60-4f08-b9d8-b6c8e7a69613

    Device Description

    Monster, Washer, Ø6.0mm, Dome, TiA

    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
    MR Unsafe
    Direct Marking Exempt
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HTN WASHER, BOLT NUT

    GMDN Terms

    Code Name
    61670 Implantable bone washer

    Identifiers

    Type ID
    Primary 00889795049940