BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Henry Schein

    DI: H65810054161 · Model: 1005416 · HENRY SCHEIN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    Henry Schein
    Primary DI
    H65810054161
    Version / Model
    1005416
    Catalog Number
    1005416
    Company Name
    HENRY SCHEIN, INC.
    Labeler DUNS
    012430880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2022-08-08
    Public Version
    1
    Public Version Date
    2022-08-16
    Public Version Status
    New
    Public Device Record Key
    3b6e5cae-c43f-424b-b33d-a30e7f28d90a

    Device Description

    K-FILES 25MM #20

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Manufacturing Date
    Yes
    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
    31878 Manual endodontic file/rasp, reusable

    Identifiers

    Type ID
    Unit of Use H65810054169
    Primary H65810054161