BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GC Fuji II®

    DI: 14548161294089 · Model: 000103 · Gc America Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GC Fuji II®
    Primary DI
    14548161294089
    Version / Model
    000103
    Catalog Number
    000103
    Company Name
    Gc America Inc.
    Labeler DUNS
    005473608
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-19
    Public Version
    1
    Public Version Date
    2022-08-29
    Public Version Status
    New
    Public Device Record Key
    296ce723-26dd-400e-b285-cf6bca6f696c

    Device Description

    GC Fuji II® Dark Gray, 1-1 Pack (1 x 15 g powder and 1 x 8 mL liquid) 1 x mixing pad & 1 x measuring scoop

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    EMA CEMENT, DENTAL

    GMDN Terms

    Code Name
    16704 Glass ionomer dental cement

    Identifiers

    Type ID
    Package 24548161294086
    Primary 14548161294089

    Customer Contacts

    Phone
    +1(708)597-0900
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    4 – 25 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    39 – 77 Degrees Fahrenheit