Adult Lumbar Puncture Tray - 18 G x 3 1/2 Inch Spinal Needle


Product Overview

Adult Lumbar Puncture Tray
N/A - 4303C


Device Description

A collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PWY

    Device Name: Lumbar Puncture Tray (Adult & Pediatric)

    Device Class: 2

    Physical State: This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    Definition: This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    Submission Type ID: 7

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    Regulation Number: 880.5570

    Third Party Flag: N

    Medical Specialty: HO


    Device Identifiers

    Device Id: 50885403057029

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403057021

    Package Quantity: 10

    Package Discontinue Date: 12/23/2023 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Case


    Device Id: 10885403057021

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos