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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sure-endo

    DI: 08809264299951 · Model: SCP-00 · SURE DENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sure-endo
    Primary DI
    08809264299951
    Version / Model
    SCP-00
    Company Name
    SURE DENT CORPORATION
    Labeler DUNS
    688273010
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-10
    Public Version
    1
    Public Version Date
    2020-04-20
    Public Version Status
    New
    Public Device Record Key
    8076790a-a340-413c-afcd-e956d7f57e01

    Device Description

    Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #00, 100 in (254cm)

    Device Characteristics

    Single Use
    Yes
    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
    MVL Cord, Retraction

    GMDN Terms

    Code Name
    46037 Gingival retraction cord, medicated

    Identifiers

    Type ID
    Primary 08809264299951

    Premarket Submissions

    Submission Number Supplement Number
    K132526 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store in a dry place.