BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EDGE ENDO

    DI: 00810988031350 · Model: EEALUT · HANDPIECE PARTS & REPAIRS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EDGE ENDO
    Primary DI
    00810988031350
    Version / Model
    EEALUT
    Catalog Number
    EEALUT
    Company Name
    HANDPIECE PARTS & REPAIRS, INC.
    Labeler DUNS
    079723355
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-20
    Public Version
    1
    Public Version Date
    2023-04-28
    Public Version Status
    New
    Public Device Record Key
    73ba4a2d-28ad-475b-8810-1c899e7ac59f

    Device Description

    EdgeApex Tester

    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
    Yes
    Has Manufacturing Date
    No
    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 00810988031350

    Premarket Submissions

    Submission Number Supplement Number
    K181087 000