BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Brasseler USA

    DI: 00887919554264 · Model: 5011702U0 · Peter Brasseler Holdings, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Brasseler USA
    Primary DI
    00887919554264
    Version / Model
    5011702U0
    Company Name
    Peter Brasseler Holdings, LLC
    Labeler DUNS
    082080136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-17
    Public Version
    1
    Public Version Date
    2023-03-27
    Public Version Status
    New
    Public Device Record Key
    3379f8b7-94f6-40f9-8c83-93ea2978e0be

    Device Description

    KFK.08.21CWS KFILE 08 21 6P

    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
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EKS FILE, PULP CANAL, ENDODONTIC

    GMDN Terms

    Code Name
    63720 Manual endodontic file/rasp, single-use

    Identifiers

    Type ID
    Primary 00887919554264