BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Renú Transoral Needle

    DI: 00856509002669 · Model: 12-000-00-ND1 · CYTOPHIL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Renú Transoral Needle
    Primary DI
    00856509002669
    Version / Model
    12-000-00-ND1
    Catalog Number
    12-000-00-ND1
    Company Name
    CYTOPHIL, INC.
    Labeler DUNS
    024222105
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-30
    Public Version
    1
    Public Version Date
    2019-11-07
    Public Version Status
    New
    Public Device Record Key
    9c1a5c43-9cb1-41c0-a7ff-73fa892f3417

    Device Description

    Renú Transoral Needle is a manual surgical instrument intended to deliver injectable soft tissue filling devices to the vocal folds for vocal fold medialization and/or treatment of vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. The needle is a single use device and is provided sterile and ready to use.

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GAA Needle, Aspiration And Injection, Disposable

    GMDN Terms

    Code Name
    38825 General-purpose endoscopic needle, single-use

    Identifiers

    Type ID
    Primary 00856509002669