30cm Water Phantom

Basic Information

• Brand Name: 30cm Water Phantom
• Primary DI: 10815411020274
• Version / Model: 10-01148-001
• Company Name: NEUROLOGICA CORP.
• Labeler DUNS: 145008178
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-13
• Public Version: 1
• Public Version Date: 2021-12-22
• Public Version Status: New
• Public Device Record Key: 2c34a097-7112-45db-b94c-3fc184d70d47

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: No
• 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
40614	General-purpose diagnostic x-ray phantom, test object	A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both calibration protocols and in subjective and quantitative evaluations of various calibration and performance characteristics of conventional and digital general-purpose x-ray imaging systems. It is also used in the assessment of the performance characteristics of associated image acquisition, display, and analysis computer programs.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815411020274	GS1

Premarket Submissions

Submission Number	Supplement Number
K170238	000