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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gelpi Retrator 9cm

    DI: G25009045100 · Model: 09-045-10 · 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
    Gelpi Retrator 9cm
    Primary DI
    G25009045100
    Version / Model
    09-045-10
    Catalog Number
    09-045-10
    Company Name
    N S SURGICAL COMPANY
    Labeler DUNS
    645681649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-18
    Public Version
    1
    Public Version Date
    2023-03-27
    Public Version Status
    New
    Public Device Record Key
    da152a23-ae7d-44f6-af90-91624fc54fb2

    Device Description

    A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
    GAD Retractor

    GMDN Terms

    Code Name
    45918 Hand-held surgical retractor, reusable

    Identifiers

    Type ID
    Primary G25009045100

    Device Sizes

    Type Value Unit Text
    Length 9 Centimeter