BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    STRIPPABLE FIBER

    DI: D807115100011 · Model: 115-100-01 · DENTSPLY SIRONA ORTHODONTICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STRIPPABLE FIBER
    Primary DI
    D807115100011
    Version / Model
    115-100-01
    Catalog Number
    115-100-01
    Company Name
    DENTSPLY SIRONA ORTHODONTICS INC.
    Labeler DUNS
    116903307
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-26
    Public Version
    5
    Public Version Date
    2021-01-18
    Public Version Status
    Update
    Public Device Record Key
    0c04aabb-80c9-48f6-90c2-aae18a8fdc6f
    Distribution End Date
    2021-01-15

    Device Description

    STRIPPABLE FIBER ACCESS PCKG

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    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
    GEX Powered laser surgical instrument

    GMDN Terms

    Code Name
    60340 Dental diode laser system

    Identifiers

    Type ID
    Primary D807115100011

    Customer Contacts

    Phone
    +1(631)357-8600
    Email
    [email protected]