BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ProShape One GlidePath; 25mm

    DI: 10810138820145 · Model: PSOGP25 · Endo Direct LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ProShape One GlidePath; 25mm
    Primary DI
    10810138820145
    Version / Model
    PSOGP25
    Company Name
    Endo Direct LLC
    Labeler DUNS
    125216703
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-10
    Public Version
    1
    Public Version Date
    2023-07-18
    Public Version Status
    New
    Public Device Record Key
    ee2d184c-8c61-42fa-8da9-9f903d834938

    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
    Yes
    PM Exempt
    Yes
    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
    EKS File, Pulp Canal, Endodontic

    GMDN Terms

    Code Name
    40529 Rotary/reciprocating endodontic file/rasp, reusable

    Identifiers

    Type ID
    Primary 10810138820145