BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Nuvis

    DI: 00853816008032 · Model: IE58OB · INTEGRATED ENDOSCOPY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Nuvis
    Primary DI
    00853816008032
    Version / Model
    IE58OB
    Catalog Number
    IE58OB
    Company Name
    INTEGRATED ENDOSCOPY, INC.
    Labeler DUNS
    127632602
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-30
    Public Version
    1
    Public Version Date
    2020-04-07
    Public Version Status
    New
    Public Device Record Key
    ee016a42-92dd-41eb-b494-9204866fcfce

    Device Description

    The obturator is a solid stainless steel needle used with cannula to close or block up the cannula opening. The obturator will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure.

    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
    Yes
    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

    Product Codes

    Code Name
    NBH Accessories, Arthroscopic

    GMDN Terms

    Code Name
    62458 Arthroscopic access cannula, reusable

    Identifiers

    Type ID
    Primary 00853816008032