BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    N/A

    DI: 04961333241170 · Model: 82123 · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    04961333241170
    Version / Model
    82123
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-01
    Public Version
    4
    Public Version Date
    2019-04-23
    Public Version Status
    Update
    Public Device Record Key
    dfdad3c7-673b-459b-99ba-16600c82df54
    Distribution End Date
    2018-07-19

    Device Description

    BIPOLAR PROBE, COAG 230D 400CM

    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
    No
    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
    Primary 04961333241170

    Premarket Submissions

    Submission Number Supplement Number
    K884836 000

    Device Sizes

    Type Value Unit Text
    Length 400.0 Centimeter
    Outer Diameter 2.3 Millimeter