BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EDGE ENDO

    DI: 10810988031302 · Model: EEALULH5 · HANDPIECE PARTS & REPAIRS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    EDGE ENDO
    Primary DI
    10810988031302
    Version / Model
    EEALULH5
    Catalog Number
    EEALULH5
    Company Name
    HANDPIECE PARTS & REPAIRS, INC.
    Labeler DUNS
    079723355
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    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
    b657e19e-d0f1-4ade-a6d3-1edc0e0705c4

    Device Description

    EdgeApex Lip Hooks (5 Pack)

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LQY Locator, Root Apex

    GMDN Terms

    Code Name
    16355 Endodontic apex locator

    Identifiers

    Type ID
    Unit of Use 00810988031305
    Primary 10810988031302

    Premarket Submissions

    Submission Number Supplement Number
    K181087 000