BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ProTaper Universal Rotary File

    DI: D716PTURAS31DEMO1 · Model: PTURAS31DEMO · TULSA DENTAL PRODUCTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    ProTaper Universal Rotary File
    Primary DI
    D716PTURAS31DEMO1
    Version / Model
    PTURAS31DEMO
    Catalog Number
    PTURAS31DEMO
    Company Name
    TULSA DENTAL PRODUCTS LLC
    Labeler DUNS
    942778564
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2022-10-26
    Public Version
    1
    Public Version Date
    2022-11-03
    Public Version Status
    New
    Public Device Record Key
    910707c1-396a-4e09-8ae3-dcaad70ef301

    Device Description

    PT Universal Demo Rotary Files 31

    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
    Yes
    Has Expiration Date
    No
    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
    63550 Rotary/reciprocating endodontic file/rasp, single-use

    Identifiers

    Type ID
    Unit of Use D716PTURAS31DEMO0
    Primary D716PTURAS31DEMO1