SYSTEM TWO LED

Basic Information

• Brand Name: SYSTEM TWO LED
• Primary DI: 00816835023271
• Version / Model: SD3D3 CNE-LCH
• Company Name: Medical Illumination International Inc.
• Labeler DUNS: 093357739
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 2
• Public Version Date: 2022-09-19
• Public Version Status: Update
• Public Device Record Key: 70208530-2f30-4e14-a43e-37a6742669dc

Device Description

SYSTEM TWO D3, DUAL, SURGICAL LIGHT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32245	Medical monitor/light mount	A permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	01816835023270	GS1	BOX	1	In Commercial Distribution
Primary	00816835023271	GS1

Premarket Submissions

Submission Number	Supplement Number
K100388	000