BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T-Crystal cartridges Opaque Pink

    DI: 07290110506292 · Model: 28mm Diam. Large 84mm long · PERFLEX LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T-Crystal cartridges Opaque Pink
    Primary DI
    07290110506292
    Version / Model
    28mm Diam. Large 84mm long
    Catalog Number
    112809-05
    Company Name
    PERFLEX LTD
    Labeler DUNS
    532176000
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-17
    Public Version
    1
    Public Version Date
    2020-06-25
    Public Version Status
    New
    Public Device Record Key
    a32d0528-748c-4b46-9439-a178b0d4ba6e

    Device Description

    5 identical cartridges sealed in a vacuum bag ; cartridge dimensions : 28mm diameter ; 84mm long ; each cartridge filled with 31Gr of T-Crystal Opaque Pink Thermoplastic pellets.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    58288 Dental appliance fabrication material, thermoplastic

    Identifiers

    Type ID
    Primary 07290110506292