BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PCD System

    DI: 08809281659417 · Model: TYP-PCDA · Taeyeon Medical co.,Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PCD System
    Primary DI
    08809281659417
    Version / Model
    TYP-PCDA
    Catalog Number
    TYP-PCDA
    Company Name
    Taeyeon Medical co.,Ltd.
    Labeler DUNS
    687607387
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-22
    Public Version
    1
    Public Version Date
    2025-09-01
    Public Version Status
    New
    Public Device Record Key
    8b63647f-47f3-4345-be8a-0dd3ae60b128

    Device Description

    CEMENT DISPENSER SYSTEM (PCD) SET A

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument
    OCJ Spinal Channeling Instrument, Vertebroplasty

    GMDN Terms

    Code Name
    35809 Orthopaedic cement dispenser

    Identifiers

    Type ID
    Primary 08809281659417