BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PDT, Inc.

    DI: 00813677020765 · Model: R113 U15-33 Scaler · PDT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PDT, Inc.
    Primary DI
    00813677020765
    Version / Model
    R113 U15-33 Scaler
    Catalog Number
    R113
    Company Name
    PDT, INC.
    Labeler DUNS
    125850144
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-30
    Public Version
    2
    Public Version Date
    2022-05-18
    Public Version Status
    Update
    Public Device Record Key
    2c438ec5-b7de-443e-8df4-34937b75fe94

    Device Description

    U15-33 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
    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
    No
    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
    EMN Scaler, Periodontic

    GMDN Terms

    Code Name
    35320 Manual dental scaler, reusable

    Identifiers

    Type ID
    Primary 00813677020765