BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Resilience

    DI: 00190730006592 · Model: FC-RESI-008 · ORTHO TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Resilience
    Primary DI
    00190730006592
    Version / Model
    FC-RESI-008
    Company Name
    ORTHO TECHNOLOGY, INC.
    Labeler DUNS
    781772017
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-12
    Public Version
    3
    Public Version Date
    2022-04-27
    Public Version Status
    Update
    Public Device Record Key
    41891abc-1f4b-4d81-a59d-b1269fd4014f
    Distribution End Date
    2022-04-26

    Device Description

    LV Flowable Composite Syringe 2gms. + 10 syringe tips

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    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
    DYH ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

    GMDN Terms

    Code Name
    31750 Orthodontic bracket adhesive

    Identifiers

    Type ID
    Primary 00190730006592

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep out of Sun
    Type
    Storage Environment Temperature
    Temperature Range
    50 – 75 Degrees Fahrenheit