BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    XP-4D

    DI: 08404535012088 · Model: 5031700U0 · Peter Brasseler Holdings, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    XP-4D
    Primary DI
    08404535012088
    Version / Model
    5031700U0
    Catalog Number
    5031700U0
    Company Name
    Peter Brasseler Holdings, LLC
    Labeler DUNS
    082080136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-31
    Public Version
    3
    Public Version Date
    2025-03-12
    Public Version Status
    Update
    Public Device Record Key
    7d1d00c2-fed7-4675-9f7d-c5af5d5d756e

    Device Description

    XP-4D BIO GP CONES STARTER 60P

    Device Characteristics

    Single Use
    Yes
    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
    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
    No

    Product Codes

    Code Name
    EKM Gutta-Percha

    GMDN Terms

    Code Name
    45081 Synthetic gutta-percha

    Identifiers

    Type ID
    Primary 08404535012088