Device
SYSTEM TWO D3, DUO, IL-CR &D3, ADJ CCT, 6G-SDI 4K
Manufacturer
Medical Illumination International Inc.
Medical Illumination International Inc.
Model: SD3CD3-CNE-LCH-4K
DI: 00816835024384
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 &D3, ADJ CCT, 6G-SDI 4K
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cf87385b-610f-43d4-9c2c-c6aa941f2149
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 - Device ID:
00816835024384
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
BOX
Item #2 - Device ID:
01816835024383
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00816835024384
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 32245
Name: Medical monitor/light mount
Definition:
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.
FDA Product Codes
FST
Light, Surgical, Fiberoptic
Premarket Submissions
Submission Number:
K100388
Supplement Number:
000