BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dentray II

    DI: D687AD330641 · Model: AD33057FG · Sultan Healthcare Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    12

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Dentray II
    Primary DI
    D687AD330641
    Version / Model
    AD33057FG
    Catalog Number
    AD33064
    Company Name
    Sultan Healthcare Inc
    Labeler DUNS
    056296981
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    12
    Record Status
    Published
    Publish Date
    2022-12-03
    Public Version
    1
    Public Version Date
    2022-12-12
    Public Version Status
    New
    Public Device Record Key
    120627c7-60ea-48f5-9ef9-df6a987b1fe7

    Device Description

    Dentray II #10S Lower Anterior Solid Package of 12

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EHY TRAY, IMPRESSION, PREFORMED

    GMDN Terms

    Code Name
    16350 Dental impression tray, single-use

    Identifiers

    Type ID
    Unit of Use D687AD330640
    Primary D687AD330641