BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPEED Reinforcing Tube

    DI: 07540295000321 · Model: 07540295000321 · Hespeler Orthodontics Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    SPEED Reinforcing Tube
    Primary DI
    07540295000321
    Version / Model
    07540295000321
    Company Name
    Hespeler Orthodontics Limited
    Labeler DUNS
    203297635
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2024-08-09
    Public Version
    1
    Public Version Date
    2024-08-19
    Public Version Status
    New
    Public Device Record Key
    9542c763-4b58-40b9-a0c4-0378ae5935e7

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZD Tube, Orthodontic

    GMDN Terms

    Code Name
    65562 Orthodontic archwire protection sleeve

    Identifiers

    Type ID
    Unit of Use 07540295900218
    Primary 07540295000321
    Previous 75402950600028