EDMS 46915 DUET INTERLINK WITH VCATH

EDMS 46915 DUET INTERLINK WITH VCATH
Duet® - 46915

A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GWM

Device Name: Device, Monitoring, Intracranial Pressure

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: N

Target Area: N/A

Regulation Number: 882.1620

Third Party Flag: Y

Medical Specialty: NE

Code: PCB

Device Name: External Cerebrospinal Fluid (Csf) Diversion

Device Class: 2

Physical State: CSF drainage system.

Definition: Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Diverts CSF in order to alter spinal cord perfusion pressures.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Central nervous system (CNS) subarachnoid and ventricular space.

Regulation Number: 882.5560

Third Party Flag: N

Medical Specialty: NE

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 Id: 00613994445384

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