BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T-Crystal cartridges Amhari/Purple Pink

    DI: 07290110506384 · Model: 22mm Diam. Medium 82mm 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 Amhari/Purple Pink
    Primary DI
    07290110506384
    Version / Model
    22mm Diam. Medium 82mm long
    Catalog Number
    112208-05
    Company Name
    PERFLEX LTD
    Labeler DUNS
    532176000
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-18
    Public Version
    1
    Public Version Date
    2020-06-26
    Public Version Status
    New
    Public Device Record Key
    7f6069e5-90e4-434c-8378-81f358113198

    Device Description

    5 identical cartridges sealed in a vacuum bag ; cartridge dimensions : 22mm diameter ; 82mm long ; each cartridge is filled with 18Gr of T-Crystal Amhari/Purple 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 07290110506384