Single Shot Nerve Block Tray (Kit) with 22 Ga. x 2 in. Stimuplex® Ultra 360® Insulated Echogenic Needle and Ultrasound Transducer Cover and Gel (SNB200U3)


Product Overview

Single Shot Nerve Block Tray (Kit) with 22 Ga. x 2 in. Stimuplex® Ultra 360® Insulated Echogenic Needle and Ultrasound Transducer Cover and Gel (SNB200U3)
Stimuplex® - 332135


Device Description

A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • 1.00
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 20.00

  • Device Sizes

  • Gauge (cannula) : 22
    • Gauge (cannula) : 22


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CAZ

    Device Name: Anesthesia Conduction Kit

    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 www.fda.gov/cdrh/ode/convkit.html. 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 www.fda.gov/cdrh/ode/convkit.html. 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: 1

    Review Panel: AN

    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 www.fda.gov/cdrh/ode/convkit.html. 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 www.fda.gov/cdrh/ode/convkit.html. 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: 868.5140

    Third Party Flag: Y

    Medical Specialty: AN


    Device Identifiers

    Device Id: 04046964767258

    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


    Device Id: 04046964767241

    Device Type: Unit of Use

    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


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