BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Parkell®

    DI: 10810000526458 · Model: SD120 · PARKELL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Parkell®
    Primary DI
    10810000526458
    Version / Model
    SD120
    Catalog Number
    SD120
    Company Name
    PARKELL, INC.
    Labeler DUNS
    009900424
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2018-09-21
    Public Version
    5
    Public Version Date
    2023-12-27
    Public Version Status
    Update
    Public Device Record Key
    04523d58-e611-4a4c-954d-1bc8f2cdf319
    Distribution End Date
    2020-03-01

    Device Description

    Round Coarse Grit FG Diamond ISO# 6801-019 (Pkg. of 10 pcs.)

    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
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    DZP Instrument, Diamond, Dental

    GMDN Terms

    Code Name
    45525 Diamond dental bur, single-use

    Identifiers

    Type ID
    Primary 10810000526458
    Unit of Use 00810000526451

    Customer Contacts

    Phone
    6312491134
    Email
    [email protected]