BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Paradigm Quantum

    DI: D948PBXPRH251 · Model: PRHT · Smarter Alloys Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    Paradigm Quantum
    Primary DI
    D948PBXPRH251
    Version / Model
    PRHT
    Catalog Number
    PBX-PR-H25
    Company Name
    Smarter Alloys Inc
    Labeler DUNS
    200106716
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2021-08-25
    Public Version
    1
    Public Version Date
    2021-09-02
    Public Version Status
    New
    Public Device Record Key
    042e6c4f-4b6b-4155-a7a5-c76f979edd17

    Device Description

    .07v taper NiTi reciprocating endodontic file, size primary, 25mm length, heat treated

    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 D948PBXPRH250
    Primary D948PBXPRH251