BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    n.a.

    DI: 04048551393307 · Model: 26055BL1-S · Karl Storz GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    n.a.
    Primary DI
    04048551393307
    Version / Model
    26055BL1-S
    Company Name
    Karl Storz GmbH & Co. KG
    Labeler DUNS
    315731430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    2bc08da7-f7ed-4fab-9ca3-8ad4d5d953be

    Device Description

    21FR BIPOLAR COAG CUTTING LOOP, POINTD

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIN COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

    GMDN Terms

    Code Name
    32684 Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

    Identifiers

    Type ID
    Primary 04048551393307
    Unit of Use 04048551393314

    Premarket Submissions

    Submission Number Supplement Number
    K122983 000