BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MiniKut

    DI: 00850001745185 · Model: 1051525 · DENTAL ENGINEERING LABORATORIES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MiniKut
    Primary DI
    00850001745185
    Version / Model
    1051525
    Company Name
    DENTAL ENGINEERING LABORATORIES, LLC
    Labeler DUNS
    026444360
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-15
    Public Version
    1
    Public Version Date
    2022-08-23
    Public Version Status
    New
    Public Device Record Key
    937d6b86-3a59-4744-84f5-79d66e33db2a

    Device Description

    MiniKut EZP Rotary NiTi Endodontic Files .15/.05, 25mm 6 Pack

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    63550 Rotary/reciprocating endodontic file/rasp, single-use

    Identifiers

    Type ID
    Primary 00850001745185

    Customer Contacts

    Phone
    805-963-2118
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    22 – 140 Degrees Fahrenheit