BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Penfield Elevator

    DI: G25008036030 · Model: 08-036-03 · N S SURGICAL COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Penfield Elevator
    Primary DI
    G25008036030
    Version / Model
    08-036-03
    Catalog Number
    08-036-03
    Company Name
    N S SURGICAL COMPANY
    Labeler DUNS
    645681649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-28
    Public Version
    1
    Public Version Date
    2023-05-08
    Public Version Status
    New
    Public Device Record Key
    896fc784-160e-43f7-a371-9ca054ecd0fe

    Device Description

    A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
    ["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Ultraviolet Light"]

    Product Codes

    Code Name
    HTE Elevator

    GMDN Terms

    Code Name
    35048 Bone lever/elevator, reusable

    Identifiers

    Type ID
    Primary G25008036030

    Device Sizes

    Type Value Unit Text
    Length 19 Centimeter