RES 44515 CSF
NA - 44515
Device Description
An implantable component of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt designed to regulate the pressure and/or flow of cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine or brain to the peritoneal cavity or heart right atrium in the management of raised CSF pressure (e.g., caused by hydrocephalus), and to permit hypodermic infusion/injection of materials into the central nervous system via the subarachnoid space; it may also be used for drainage of CSF. It consists of a subcutaneous puncturable dome with catheter connections, and a non-return and/or mechanical valve that typically opens at a pre-set pressure and may be non-invasively adjusted.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
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 IdentifiersDevice Id: 00643169472365
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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