BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Greenwald Surgical Company, Inc.

    DI: 10801334000165 · Model: 54240-00 · GRACE MANUFACTURING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Greenwald Surgical Company, Inc.
    Primary DI
    10801334000165
    Version / Model
    54240-00
    Catalog Number
    U413
    Company Name
    GRACE MANUFACTURING, INC.
    Labeler DUNS
    607903382
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-31
    Public Version
    3
    Public Version Date
    2023-07-25
    Public Version Status
    Update
    Public Device Record Key
    19e0d3db-e940-4452-803f-e6d1e51c65d5

    Device Description

    Zipser Meatus Clamp

    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, Liquid Chemical

    Product Codes

    Code Name
    FHA Clamp, Penile

    GMDN Terms

    Code Name
    35803 Surgical penis clamp, reusable

    Identifiers

    Type ID
    Primary 10801334000165