KIT 44421 STRATA NSC LP OPEN LUMBAR


Product Overview

KIT 44421 STRATA NSC LP OPEN LUMBAR
Strata® - 44421


Device Description

An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity where it can be absorbed into the body, as a treatment for raised CSF pressure (e.g., caused by hydrocephalus). It consists of fully-implantable interconnected components: a spinal catheter implanted into subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a puncturable port/reservoir for sampling/infusion; a peritoneal catheter implanted into the peritoneal cavity; some types incorporate a subcutaneous anchor for component connection/positioning. Disposable devices associated with implantation may be included.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 120.0 Centimeter
    • Length: 120.0 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JXG

    Device Name: Shunt, Central Nervous System And Components

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 882.5550

    Third Party Flag: N

    Medical Specialty: NE


    Device Identifiers

    Device Id: 00643169010789

    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


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