BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premier H-FILES

    DI: D6919053400 · Model: 9053400 · PREMIER DENTAL PRODUCTS COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Premier H-FILES
    Primary DI
    D6919053400
    Version / Model
    9053400
    Company Name
    PREMIER DENTAL PRODUCTS COMPANY
    Labeler DUNS
    014789663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-17
    Public Version
    1
    Public Version Date
    2023-10-25
    Public Version Status
    New
    Public Device Record Key
    5b6e51d5-d9e1-4f4e-8f5d-85251131a877

    Device Description

    FILES HEDSTROM PKG 6 21MM 10

    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
    Yes
    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
    63720 Manual endodontic file/rasp, single-use

    Identifiers

    Type ID
    Primary D6919053400