BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Parkell®

    DI: 10810000527028 · Model: S521 · PARKELL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    30

    Basic Information

    Brand Name
    Parkell®
    Primary DI
    10810000527028
    Version / Model
    S521
    Catalog Number
    S521
    Company Name
    PARKELL, INC.
    Labeler DUNS
    009900424
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    30
    Record Status
    Published
    Publish Date
    2019-08-16
    Public Version
    6
    Public Version Date
    2023-12-27
    Public Version Status
    Update
    Public Device Record Key
    5e6571c3-2934-40f7-8020-b97b6e67dd9a
    Distribution End Date
    2020-07-09

    Device Description

    Mixing Tip for 10ml Cartridge with Brown Base & Clear Mixer (Pkg. of 30 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
    No
    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
    No

    Product Codes

    Code Name
    ELW Material, Impression

    GMDN Terms

    Code Name
    58399 Dental material mixing nozzle

    Identifiers

    Type ID
    Primary 10810000527028
    Unit of Use 00810000527021

    Customer Contacts

    Phone
    6312491134
    Email
    [email protected]