BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AquaBeam Handpiece

    DI: B6143103011 · Model: 310301 · PROCEPT BioRobotics Corporation
    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
    AquaBeam Handpiece
    Primary DI
    B6143103011
    Version / Model
    310301
    Company Name
    PROCEPT BioRobotics Corporation
    Labeler DUNS
    016646472
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-11
    Public Version
    4
    Public Version Date
    2026-01-19
    Public Version Status
    Update
    Public Device Record Key
    8c93d69e-5f8e-402c-a6ad-5653441c8ed2

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PZP Fluid Jet Removal System

    GMDN Terms

    Code Name
    47559 Water jet knife system handpiece, single-use

    Identifiers

    Type ID
    Primary B6143103011

    Premarket Submissions

    Submission Number Supplement Number
    DEN170024 000