BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EDENTA

    DI: E312PFXDS31 · Model: PFXDS3 · EDENTA ETABLISSEMENT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    EDENTA
    Primary DI
    E312PFXDS31
    Version / Model
    PFXDS3
    Company Name
    EDENTA ETABLISSEMENT
    Labeler DUNS
    448002915
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2022-02-03
    Public Version
    1
    Public Version Date
    2022-02-11
    Public Version Status
    New
    Public Device Record Key
    7c26876f-752c-45f7-a2f8-e5fd7cd5d9ab

    Device Description

    Diamonstrip perforated

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Manufacturing Date
    Yes
    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
    DZP INSTRUMENT, DIAMOND, DENTAL

    GMDN Terms

    Code Name
    63358 Dental abrasive strip, reusable

    Identifiers

    Type ID
    Unit of Use E312PFXDS3101
    Primary E312PFXDS31