CuratOR

Basic Information

• Brand Name: CuratOR
• Primary DI: 04995047068570
• Version / Model: MIR-1
• Catalog Number: MIR-1
• Company Name: EIZO CORPORATION
• Labeler DUNS: 691033005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-29
• Public Version: 1
• Public Version Date: 2024-09-06
• Public Version Status: New
• Public Device Record Key: 2f698f55-2751-4a5f-b8ad-8648b54c1b26

Device Description

4K Medical Imaging Recorder

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: Yes
• 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
LMB	Device, Digital Image Storage, Radiological	Radiology	892.2010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63260	Medical video image recorder	An electrically-powered device designed to be used in conjunction with video endoscopes, radiological equipment, and/or surgical video imaging devices (e.g., surgical microscope, camera) to digitally record video images for subsequent playback; it is not intended for distribution/routing of image data within a network (i.e., not a medical image management system). It is typically a portable device that may incorporate a small screen intended only to reference image capture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04995047068570	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]