BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NA

    DI: M595D625L1 · Model: D625L · PARKELL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    NA
    Primary DI
    M595D625L1
    Version / Model
    D625L
    Catalog Number
    D625L
    Company Name
    PARKELL, INC.
    Labeler DUNS
    009900424
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2019-03-29
    Public Version Status
    Update
    Public Device Record Key
    3ff569bd-a48e-4128-bd57-611b65641356
    Distribution End Date
    2019-01-01

    Device Description

    Long Probes for Gentle Pulse™ & Digitest™ Pulptesters (Pkg. of 2 pcs.)

    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
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EAT Tester, Pulp

    GMDN Terms

    Code Name
    13187 Dental pulp analysis system

    Identifiers

    Type ID
    Primary M595D625L1
    Unit of Use M595D625L0

    Customer Contacts

    Phone
    6312491134
    Email
    [email protected]