BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Novo Surgical Inc.

    DI: 00842331154584 · Model: N6819-04CC · NOVO SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Novo Surgical Inc.
    Primary DI
    00842331154584
    Version / Model
    N6819-04CC
    Catalog Number
    N6819-04CC
    Company Name
    NOVO SURGICAL, INC.
    Labeler DUNS
    033029433
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-12
    Public Version
    1
    Public Version Date
    2022-11-21
    Public Version Status
    New
    Public Device Record Key
    0957c4c5-c7f7-4a91-9608-bd8ff8e935fd

    Device Description

    ceramic cut micro kerrison rongeur, thin footplates, black ceramic coat, small handles, 9.0 mm opening, 40 degree up, 3.0 mm bite, 9" (22.9 cm)

    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
    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
    HTX Rongeur

    GMDN Terms

    Code Name
    33442 Craniofacial rongeur, reusable

    Identifiers

    Type ID
    Primary 00842331154584

    Customer Contacts

    Phone
    1877-860-6686
    Email
    [email protected]