BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sure Endo

    DI: 00850079280199 · Model: Sure-Cord 00 · Hexa Dental
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Sure Endo
    Primary DI
    00850079280199
    Version / Model
    Sure-Cord 00
    Company Name
    Hexa Dental
    Labeler DUNS
    096955608
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-22
    Public Version
    1
    Public Version Date
    2026-01-30
    Public Version Status
    New
    Public Device Record Key
    af6a5d96-59fb-472f-9594-ebece274a221

    Device Description

    Knitted Retraction Cord #00 - 100 Inch (254cm) Brown

    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
    Yes
    Has Serial Number
    Yes
    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
    MVL Cord, Retraction

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Primary 00850079280199