BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mollosil Plus Glaze and Catalyst

    DI: D814FIXX41 · Model: FIXX4 · PROTECH PROFESSIONAL PRODUCTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mollosil Plus Glaze and Catalyst
    Primary DI
    D814FIXX41
    Version / Model
    FIXX4
    Company Name
    PROTECH PROFESSIONAL PRODUCTS INC
    Labeler DUNS
    117374900
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-25
    Public Version
    3
    Public Version Date
    2018-08-09
    Public Version Status
    Update
    Public Device Record Key
    db970d24-5d37-47ce-8f20-3c47ca80e930

    Device Description

    Mollosil Plue Glaze and Catalyst (2x7ml), Silicone Glaze and Catalyst and Nipples

    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 D814FIXX41