BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Darby Dental Supply, LLC

    DI: 00889813028155 · Model: 9510155 · DARBY DENTAL SUPPLY, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Darby Dental Supply, LLC
    Primary DI
    00889813028155
    Version / Model
    9510155
    Catalog Number
    9510155
    Company Name
    DARBY DENTAL SUPPLY, LLC
    Labeler DUNS
    825137818
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-18
    Public Version
    1
    Public Version Date
    2020-01-27
    Public Version Status
    New
    Public Device Record Key
    2b66970b-f08c-4f37-960e-d1b164a9f106

    Device Description

    TUN U/S TIP E2 W/O DMND S-TYP

    Device Characteristics

    Single Use
    No
    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
    No
    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
    ELC Scaler, ultrasonic

    GMDN Terms

    Code Name
    46035 Ultrasonic dental scaling/debridement system handpiece tip, endodontic

    Identifiers

    Type ID
    Primary 00889813028155

    Customer Contacts

    Phone
    +1(516)688-6800 ext. 6431
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K182145 000