BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    TBS dental

    DI: G149630010 · Model: 63001 · ACME ENTERPRISE.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TBS dental
    Primary DI
    G149630010
    Version / Model
    63001
    Catalog Number
    63001
    Company Name
    ACME ENTERPRISE.
    Labeler DUNS
    645459892
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-11-24
    Public Version
    1
    Public Version Date
    2021-12-02
    Public Version Status
    New
    Public Device Record Key
    b5ff4ac7-b243-4175-b745-00b2ba861f28
    Distribution End Date
    2021-11-25

    Device Description

    Scaler

    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
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EMJ Elevator, Surgical, Dental

    GMDN Terms

    Code Name
    35320 Manual dental scaler, reusable

    Identifiers

    Type ID
    Primary G149630010