BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Brasseler USA

    DI: 08404535024937 · Model: 5032030U0 · Peter Brasseler Holdings, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Brasseler USA
    Primary DI
    08404535024937
    Version / Model
    5032030U0
    Catalog Number
    5032030U0
    Company Name
    Peter Brasseler Holdings, LLC
    Labeler DUNS
    082080136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-23
    Public Version
    1
    Public Version Date
    2026-03-31
    Public Version Status
    New
    Public Device Record Key
    e46d9a63-d59f-4c06-9196-5fd2452ecd32

    Device Description

    PKT44 PKT 4 LAB #4 HANDLE 1P

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EIK CARVER, WAX, DENTAL

    GMDN Terms

    Code Name
    35793 Dental restoration carver, amalgam, reusable

    Identifiers

    Type ID
    Primary 08404535024937