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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Select Calcium Hydroxide Liner LC

    DI: 07540208000387 · Model: CAL-LINER · Zendo Direct AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Select Calcium Hydroxide Liner LC
    Primary DI
    07540208000387
    Version / Model
    CAL-LINER
    Catalog Number
    CAL-LINER
    Company Name
    Zendo Direct AG
    Labeler DUNS
    486717338
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-26
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    97e09edf-86f0-4e96-9de8-26634bbadb46

    Device Description

    Light cure radiopaque calcium hydroxide liner - 2 ml syringe

    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
    EJK Liner, Cavity, Calcium Hydroxide

    GMDN Terms

    Code Name
    62199 Calcium hydroxide dental cement

    Identifiers

    Type ID
    Package 17540208000384
    Primary 07540208000387

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    39 – 77 Degrees Fahrenheit