EDMS 46918 CLEAR-SITE LASER LEVEL

EDMS 46918 CLEAR
Clear-Site® - 46918

A fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Device Id: 00613994450661

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