BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Inge Spreader (Child) 16cm

    DI: G25009069160 · Model: 09-069-16 · N S SURGICAL COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Inge Spreader (Child) 16cm
    Primary DI
    G25009069160
    Version / Model
    09-069-16
    Catalog Number
    09-069-16
    Company Name
    N S SURGICAL COMPANY
    Labeler DUNS
    645681649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-02
    Public Version
    1
    Public Version Date
    2023-09-11
    Public Version Status
    New
    Public Device Record Key
    635f036c-c186-48c7-ab68-70ad2cd2c1f2

    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)
    Yes
    Over the Counter (OTC)
    Yes
    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", "Ultraviolet Light", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    GAD Retractor

    GMDN Terms

    Code Name
    45918 Hand-held surgical retractor, reusable

    Identifiers

    Type ID
    Primary G25009069160

    Device Sizes

    Type Value Unit Text
    Length 16 Centimeter