BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Paradigm BX

    DI: D948PBXM2N251 · Model: M2 · Smarter Alloys Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    Paradigm BX
    Primary DI
    D948PBXM2N251
    Version / Model
    M2
    Catalog Number
    PBX-M2-N25
    Company Name
    Smarter Alloys Inc
    Labeler DUNS
    200106716
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2020-05-21
    Public Version
    1
    Public Version Date
    2020-05-29
    Public Version Status
    New
    Public Device Record Key
    69d4e51d-3213-456e-b2f9-10dadec371cd

    Device Description

    Multi-taper NiTi rotary endodontic file, size M2, 25mm length

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    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
    EKS File, Pulp Canal, Endodontic

    GMDN Terms

    Code Name
    63550 Rotary/reciprocating endodontic file/rasp, single-use

    Identifiers

    Type ID
    Unit of Use D948PBXM2N250
    Primary D948PBXM2N251