BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORTHOSOURCE

    DI: D9115670410 · Model: 567-041 · ORTHOSOURCE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ORTHOSOURCE
    Primary DI
    D9115670410
    Version / Model
    567-041
    Company Name
    ORTHOSOURCE
    Labeler DUNS
    151289394
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-12
    Public Version
    2
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    cff6ea48-dfb5-4fe8-8fb5-3cabc138f667

    Device Description

    Blue Etch 1.2 cc syringe

    Device Characteristics

    Single Use
    No
    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
    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
    EBC Sealant, Pit And Fissure, And Conditioner

    GMDN Terms

    Code Name
    36153 Dental tooth-etching solution

    Identifiers

    Type ID
    Package D911557041503
    Primary D9115670410
    Package D911567041202
    Package D91156704141

    Premarket Submissions

    Submission Number Supplement Number
    K861245 000