BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PKS Plasma J-Hook 5mm/24cm

    DI: 00821925041745 · Model: 956005PC · Gyrus Acmi, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PKS Plasma J-Hook 5mm/24cm
    Primary DI
    00821925041745
    Version / Model
    956005PC
    Company Name
    Gyrus Acmi, Inc.
    Labeler DUNS
    007198742
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-04
    Public Version
    6
    Public Version Date
    2023-08-02
    Public Version Status
    Update
    Public Device Record Key
    a2aa49cf-277a-4b7d-a346-ebbc78565f31
    Distribution End Date
    2017-03-21

    Device Description

    PKS Plasma J-Hook 5mm/24cm

    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
    GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

    GMDN Terms

    Code Name
    57944 Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

    Identifiers

    Type ID
    Package 00821925009738
    Primary 00821925041745

    Premarket Submissions

    Submission Number Supplement Number
    K050460 000