BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K-file hand instrument

    DI: D716KFS035311 · Model: KFS03531 · TULSA DENTAL PRODUCTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K-file hand instrument
    Primary DI
    D716KFS035311
    Version / Model
    KFS03531
    Catalog Number
    KFS03531
    Company Name
    TULSA DENTAL PRODUCTS LLC
    Labeler DUNS
    942778564
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-16
    Public Version
    1
    Public Version Date
    2022-08-24
    Public Version Status
    New
    Public Device Record Key
    810b47e3-ad97-4df2-9dd6-e1c6d58d468a

    Device Description

    K FILE: 035 31MM LEXICON STERILIZED

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    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
    EKS FILE, PULP CANAL, ENDODONTIC

    GMDN Terms

    Code Name
    31878 Manual endodontic file/rasp, reusable

    Identifiers

    Type ID
    Primary D716KFS035311