BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PolypVac®

    DI: 00862519000328 · Model: 4.0mm Microdebrider · LAURIMED, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PolypVac®
    Primary DI
    00862519000328
    Version / Model
    4.0mm Microdebrider
    Catalog Number
    FG-000017
    Company Name
    LAURIMED, LLC
    Labeler DUNS
    622446255
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-10
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    00db9859-c529-4023-8887-2d7fad91a443

    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
    Yes
    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
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    GMDN Terms

    Code Name
    55363 ENT shaver system handpiece

    Identifiers

    Type ID
    Primary 00862519000328
    Package 00862519000335