BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Permaflex

    DI: D814FIX41 · Model: FIX4 · PROTECH PROFESSIONAL PRODUCTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    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
    Permaflex
    Primary DI
    D814FIX41
    Version / Model
    FIX4
    Catalog Number
    FIX4
    Company Name
    PROTECH PROFESSIONAL PRODUCTS INC
    Labeler DUNS
    117374900
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    4
    Public Version Date
    2019-05-20
    Public Version Status
    Update
    Public Device Record Key
    08ea3ff0-8f1e-4b47-b14e-f842d2e03f75
    Distribution End Date
    2016-10-27

    Device Description

    Permaflex Glaze and Catalyst

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBI Resin, Denture, Relining, Repairing, Rebasing

    GMDN Terms

    Code Name
    34769 Denture reliner, elastic, short-term

    Identifiers

    Type ID
    Primary D814FIX41