SYSTEM TWO LED

GUDID 00816835021383

SYSTEM TWO D3, TRIO W/HD ON-ARM CAM, W/ADJ CCT

MEDICAL ILLUMINATION INTERNATIONAL INC.

Medical monitor/light mount
Primary Device ID00816835021383
NIH Device Record Key564aa30b-42f2-4343-9800-94b732dcb0f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYSTEM TWO LED
Version Model NumberSD3D3P3-CNE
Company DUNS093357739
Company NameMEDICAL ILLUMINATION INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816835021383 [Primary]
GS101816835021382 [Package]
Package: BOX [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSTLight, Surgical, Fiberoptic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-13
Device Publish Date2016-09-23

On-Brand Devices [SYSTEM TWO LED]

00816835021475SYSTEM TWO D3, QUAD, IL-CR & D3, W/2 MON ARMS & ADJ CCT
00816835021468SYSTEM TWO D3, QUAD, W/MON ARM & P3, W/ADJ CCT
00816835021451SYSTEM TWO D3, QUAD W/2 MONITOR ARMS, ADJ CCT
00816835021444SYSTEM TWO D3, TRIO, IL-CR, W/2 MONITOR ARMS, ADJ CCT
00816835021437SYSTEM TWO D3, TRIO, IL-CR & D3, W/MONITOR ARMS, ADJ CCT
00816835021420SYSTEM TWO D3, TRIO, IL-CR & DUO D3, ADJ CCT
00816835021413SYSTEM TWO D3, TRIO W/2 MONITOR ARMS, ADJ CCT
00816835021406SYSTEM TWO D3, TRIO, W/MON ARM ADJ CCT
00816835021390SYSTEM TWO D3, TRIO, ADJ CCT
00816835021383SYSTEM TWO D3, TRIO W/HD ON-ARM CAM, W/ADJ CCT
00816835021376SYSTEM TWO D3, DUO, IL-CR, W/MONITOR ARM, ADJ CCT
00816835021369SYSTEM TWO D3, DUO, IL-CR & D3, ADJ CCT
00816835021352SYSTEM TWO D3, DUO W/ON-ARM CAMERA, ADJ CCT
00816835021345SYSTEM TWO D3, DUO, W/MON ARM ADJ CCT
00816835021338SYSTEM TWO D3, DUO ADJ CCT
00816835021321SYSTEM TWO D3, SOLO, IL-CR, ADJ CCT
00816835021314SYSTEM TWO D3, SOLO, ADJ CCT
00816835021307SYSTEM TWO D3, QUAD, IL-CR & D3 W/2 MONITOR ARMS
00816835021291SYSTEM TWO D3, QUAD, DUAL D3 & MONITOR ARM & HD CAMERA
00816835021284SYSTEM TWO D3, QUAD, DUAL D3 & DUAL MONITOR ARMS
00816835021277SYSTEM TWO D3, TRIO, W/MON ARM
00816835021260SYSTEM TWO D3, TRIO, W/2 MON ARMS
00816835021253SYSTEM TWO D3, TRIO, IL-CR W/2 MONITOR ARMS
00816835021246SYSTEM TWO D3, TRIO, IL-CR & D3 W/MONITOR ARM
00816835021239SYSTEM TWO D3, TRIO, DUO D3 & HD CAMERA
00816835021222SYSTEM TWO D3, TRIO, IL-CR AND DUAL D3
00816835021215SYSTEM TWO D3, TRIO
00816835021208SYSTEM TWO D3, DUO, W/HD CAM
00816835021192SYSTEM TWO D3, DUO, IL-CR W/MONITOR ARM
00816835021185SYSTEM TWO D3, DUO, W/MON ARM
00816835021178SYSTEM TWO D3, DUO, IL-CR & D3
00816835021161SYSTEM TWO D3, DUO
00816835021154SYSTEM TWO D3, SOLO, IL-CR
00816835021147SYSTEM TWO D3, SOLO
00816835021130SYSTEM TWO LED, QUAD W/ MON ARM & BT HD CAMERA
00816835021123SYSTEM TWO LED, QUAD W/ MON ARM & BT HD CAMERA
00816835021116SYSTEM TWO LED, QUAD W/ MON ARM & HD CAMERA
00816835021109SYSTEM TWO LED, QUAD W/ MON ARM & HD CAMERA
00816835021093SYSTEM TWO LED, QUAD W/2 MON ARMS
00816835021086SYSTEM TWO LED, QUAD W/2 MON ARMS
00816835021079SYSTEM TWO LED, TRIO W/2 MON ARMS
00816835021062SYSTEM TWO LED, TRIO W/2 MON ARMS
00816835021055SYSTEM TWO LED, TRIO W/ MON ARM
00816835021048SYSTEM TWO LED, TRIO W/ MON ARM
00816835021031SYSTEM TWO LED, TRIO
00816835021024SYSTEM TWO LED, TRIO
00816835021017SYSTEM TWO LED, TRIO, VR
00816835021000SYSTEM TWO LED, TRIO, VR
00816835020997SYSTEM TWO LED, TRIO W/ BT HD CAM
00816835020980SYSTEM TWO LED, TRIO W/ BT HD CAM
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.