BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SL3®

    DI: D813ZLR20030 · Model: ZLR2003 · DEN-MAT HOLDINGS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SL3®
    Primary DI
    D813ZLR20030
    Version / Model
    ZLR2003
    Catalog Number
    ZLR2003
    Company Name
    DEN-MAT HOLDINGS, LLC
    Labeler DUNS
    809857704
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-22
    Public Version
    1
    Public Version Date
    2022-09-30
    Public Version Status
    New
    Public Device Record Key
    dc0fa92b-7a9f-4a88-8d48-2ad8b0440f44

    Device Description

    SL3 UNIFIBER SYSTEM

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    60340 Dental diode laser system

    Identifiers

    Type ID
    Primary D813ZLR20030

    Customer Contacts

    Phone
    18004336628
    Email
    [email protected]