BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Medro Mallet With Plastic Caps

    DI: G25012251250 · Model: 12-251-25 · N S SURGICAL COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Medro Mallet With Plastic Caps
    Primary DI
    G25012251250
    Version / Model
    12-251-25
    Catalog Number
    12-251-25
    Company Name
    N S SURGICAL COMPANY
    Labeler DUNS
    645681649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-29
    Public Version
    1
    Public Version Date
    2023-05-08
    Public Version Status
    New
    Public Device Record Key
    e05850fb-e412-42ad-9d4d-6ea753c7ac7b

    Device Description

    A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Ultraviolet Light", "Ethylene Oxide"]

    Product Codes

    Code Name
    FZY Hammer, Surgical

    GMDN Terms

    Code Name
    32312 Surgical mallet

    Identifiers

    Type ID
    Primary G25012251250

    Device Sizes

    Type Value Unit Text
    Length 18 Centimeter
    Device Size Text, specify Caps Size 24mm