EDMS 46918 CLEAR
Clear-Site® - 46918
Device Description
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.
Environmental Conditions
- Keep Dry
- 30.00
- 10.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice 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
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