OPTION, NL4X00 WS-240V-S

Basic Information

• Brand Name: OPTION, NL4X00 WS-240V-S
• Primary DI: 10815411020809
• Version / Model: 0-00132-002
• Company Name: NEUROLOGICA CORP.
• Labeler DUNS: 145008178
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-15
• Public Version: 1
• Public Version Date: 2023-08-23
• Public Version Status: New
• Public Device Record Key: ab37b00d-05b5-435d-8f32-c0634527407e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36572	CT system workstation	A device that is a component of a computed tomography (CT) system and which is designed to receive and transmit data both on-line and off-line. It is typically located at a site remote from the operator's console. It differs from the operator console in that it does not contain the controls for the direct operation of the CT system. It is configured to provide the capability to further process, manipulate and/or view patient images and information collected from the CT system and possibly other related x-ray based imaging systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815411020809	GS1

Premarket Submissions

Submission Number	Supplement Number
K170238	000
K213649	000