BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Chlor-XTRA

    DI: 10818207020502 · Model: 503850 · Vista Dental
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Chlor-XTRA
    Primary DI
    10818207020502
    Version / Model
    503850
    Company Name
    Vista Dental
    Labeler DUNS
    036623932
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2018-08-06
    Public Version
    4
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    bc63ed82-fbc0-430d-a382-d085ac9d79d7

    Device Description

    Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation, debridement and cleansing of root canals during and after instrumentation. 12ml pre-filled syringes.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KJJ Cleanser, Root Canal

    GMDN Terms

    Code Name
    59523 Antimicrobial wound irrigation solution

    Identifiers

    Type ID
    Primary 10818207020502
    Unit of Use 00818207020505