BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Greenwald Surgical Company, Inc.

    DI: 10801334013929 · Model: 58950-00 · GRACE MANUFACTURING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Greenwald Surgical Company, Inc.
    Primary DI
    10801334013929
    Version / Model
    58950-00
    Catalog Number
    U515S
    Company Name
    GRACE MANUFACTURING, INC.
    Labeler DUNS
    607903382
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2019-03-21
    Public Version Status
    Update
    Public Device Record Key
    062de0c8-a34d-410f-b5dd-cd6e3e151839

    Device Description

    Roth Grip-Tip Urethral Suture Guide. Assist in reanastomosing urethra and bladder neck after prostatectomy

    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
    ["Liquid Chemical", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    FFL Dislodger, Stone, Basket, Ureteral, Metal

    GMDN Terms

    Code Name
    32357 Suturing needle, reusable

    Identifiers

    Type ID
    Primary 10801334013929