BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Straumann SIRIOS X3

    DI: 06973993440303 · Model: ST 300E · Alliedstar Medical Equipment Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Straumann SIRIOS X3
    Primary DI
    06973993440303
    Version / Model
    ST 300E
    Catalog Number
    STS-6583527
    Company Name
    Alliedstar Medical Equipment Co., Ltd.
    Labeler DUNS
    703541803
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-14
    Public Version
    1
    Public Version Date
    2025-08-22
    Public Version Status
    New
    Public Device Record Key
    ee552647-bb33-4487-9054-359c29ccd34b

    Device Description

    Straumann SIRIOS™ X3 Intraoral scanner Handpiece

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

    GMDN Terms

    Code Name
    63669 Intraoral optical scanning system

    Identifiers

    Type ID
    Primary 06973993440303