BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WaveOne Rotary File

    DI: D716WOLDEMO251 · Model: WOLDEMO25 · TULSA DENTAL PRODUCTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    WaveOne Rotary File
    Primary DI
    D716WOLDEMO251
    Version / Model
    WOLDEMO25
    Catalog Number
    WOLDEMO25
    Company Name
    TULSA DENTAL PRODUCTS LLC
    Labeler DUNS
    942778564
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    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
    3edc9267-63bc-405f-8163-70ee37384288

    Device Description

    WaveOne Demo Recip File Lg 25

    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
    DZA DRILL, DENTAL, INTRAORAL

    GMDN Terms

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

    Identifiers

    Type ID
    Unit of Use D716WOLDEMO250
    Primary D716WOLDEMO251