Device
SYSTEM TWO D3, DUO, IL-CR, W/MON, ADJ CCT, 6G-SDI 4K
Manufacturer
Medical Illumination International Inc.
Medical Illumination International Inc.
Model: SD3CM1-CNE-LCH-4K
DI: 00816835024483
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
SYSTEM TWO D3, DUO, IL-CR, W/MON, ADJ CCT, 6G-SDI 4K
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
02473e2a-88b2-4d00-9a2a-fc26bbe35a12
Distribution Status:
In Commercial Distribution
DUNS Number:
093357739
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
BOX
Item #1 - Device ID:
01816835024482
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00816835024483
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00816835024483
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 12282
Name: Operating room light
Definition:
A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.
FDA Product Codes
FST
Light, Surgical, Fiberoptic
Premarket Submissions
Submission Number:
K100388
Supplement Number:
000