BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Greenwald Surgical Company, Inc.

    DI: 10801334001551 · Model: 51850-00 · 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
    10801334001551
    Version / Model
    51850-00
    Catalog Number
    U267
    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
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f0143bd5-ef8d-43bc-b1e0-e884bb12c7ff

    Device Description

    Orandi Resectoscope Injection Needle

    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", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

    GMDN Terms

    Code Name
    32600 Gynaecological cerclage needle

    Identifiers

    Type ID
    Primary 10801334001551