BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PDT, Inc.

    DI: 00813677024107 · Model: R931 Pineyro Arch™ Kit (Instruments Only) · 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
    00813677024107
    Version / Model
    R931 Pineyro Arch™ Kit (Instruments Only)
    Catalog Number
    R931
    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
    1
    Public Version Date
    2021-05-10
    Public Version Status
    New
    Public Device Record Key
    e086602c-6697-4dde-9108-c02f6554d9d8

    Device Description

    Kit containing: R630 Pineyro Arch™ Ti 1 R631 Pineyro Arch™ Ti 2 R632 Pineyro Arch™ Ti 3 R633 Pineyro Arch™ Ti 4

    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
    ECP Instrument, Ligature Tucking, Orthodontic

    GMDN Terms

    Code Name
    35320 Manual dental scaler, reusable

    Identifiers

    Type ID
    Primary 00813677024107