- Physicians Office Resource

EDMS 46917 DUET INTERLINK WITH LCATH
Duet® - 46917

Device Description

A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device.

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: 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 Identifiers

Device Id: 00763000624804

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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