BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    n.a.

    DI: 04048551057100 · Model: 13991DA · Karl Storz GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    n.a.
    Primary DI
    04048551057100
    Version / Model
    13991DA
    Company Name
    Karl Storz GmbH & Co. KG
    Labeler DUNS
    315731430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    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
    11b310b2-5874-4999-b780-f8f0d224b65d

    Device Description

    Sealing cap working channel 10 pcs

    Device Characteristics

    Single Use
    No
    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Ethylene Oxide", "Hydrogen Peroxide", "Peracetic Acid", "Liquid Chemical"]

    Product Codes

    Code Name
    FDF Colonoscope and accessories, flexible/rigid

    GMDN Terms

    Code Name
    37085 Rigid endoscope working guide

    Identifiers

    Type ID
    Primary 04048551057100
    Unit of Use 04048551259627

    Premarket Submissions

    Submission Number Supplement Number
    K063585 000