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    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

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    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