BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premier GATES

    DI: D6919055001 · Model: 9055001 · PREMIER DENTAL PRODUCTS COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Premier GATES
    Primary DI
    D6919055001
    Version / Model
    9055001
    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
    2
    Public Version Date
    2024-04-17
    Public Version Status
    Update
    Public Device Record Key
    bbf0c70f-5000-4aeb-811e-b6878b48c81c

    Device Description

    DRILLS GATES GLIDDEN BX 6 #1

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZA Drill, Dental, Intraoral

    GMDN Terms

    Code Name
    31876 Endodontic enlarger, reusable

    Identifiers

    Type ID
    Primary D6919055001