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    FDA UDI In Commercial Distribution 🇺🇸 United States

    IEC-Innoview GmbH

    DI: B192300348000 · Model: 30-0348-00 · INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IEC-Innoview GmbH
    Primary DI
    B192300348000
    Version / Model
    30-0348-00
    Catalog Number
    30-0348-00
    Company Name
    INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
    Labeler DUNS
    010741028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-24
    Public Version
    4
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    d02f16ea-ebb0-4dff-8d34-3c984d0e0ed6

    Device Description

    2.9 mm, 30 deg. Cystoscope, l=302mm, autoclavable

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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

    Product Codes

    Code Name
    FAJ Cystoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    17145 Rigid optical cystoscope

    Identifiers

    Type ID
    Primary B192300348000

    Premarket Submissions

    Submission Number Supplement Number
    K992983 000

    Device Sizes

    Type Value Unit Text
    Angle 30 degree
    Outer Diameter 2.9 Millimeter
    Length 302 Millimeter