BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accurator

    DI: 00990010301221 · Model: AL2080 · Beyes Dental Canada Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Accurator
    Primary DI
    00990010301221
    Version / Model
    AL2080
    Catalog Number
    Accurator A2
    Company Name
    Beyes Dental Canada Inc
    Labeler DUNS
    244261462
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-10
    Public Version
    1
    Public Version Date
    2023-05-18
    Public Version Status
    New
    Public Device Record Key
    6d0d0aad-2682-43e7-bb72-e0890ca66cb9

    Device Description

    Accurator A2, Apex Locator, compatible with G2 Endo Motor

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LQY Locator, Root Apex

    GMDN Terms

    Code Name
    16355 Endodontic apex locator

    Identifiers

    Type ID
    Primary 00990010301221

    Premarket Submissions

    Submission Number Supplement Number
    K181087 000