BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Brasseler USA Surgical Power & Accessories

    DI: 00887919502890 · Model: 5008738M0 · 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 Surgical Power & Accessories
    Primary DI
    00887919502890
    Version / Model
    5008738M0
    Company Name
    Peter Brasseler Holdings, LLC
    Labeler DUNS
    082080136
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-13
    Public Version
    4
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    25be3fa2-b88c-4217-bb2e-139d928920f0
    Distribution End Date
    2023-11-17

    Device Description

    XKP-X110A NOSEPIECE ATTACHMENT EXTRA LONG ANGLED, 110MM

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

    GMDN Terms

    Code Name
    58189 Bone/joint surgical power tool motorized handpiece/set, pneumatic

    Identifiers

    Type ID
    Primary 00887919502890

    Premarket Submissions

    Submission Number Supplement Number
    K030172 000