iLumin 200529

GUDID 00893872001073

Optical Light Source- Fiberoptic Illuminator

ELLEX ISCIENCE

Ophthalmic infusion/aspiration cannula, illuminating, single-use
Primary Device ID00893872001073
NIH Device Record Key745d58ab-90e5-4f74-bc64-29f15de460dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameiLumin
Version Model NumberFI-100
Catalog Number200529
Company DUNS079755637
Company NameELLEX ISCIENCE
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com

Device Dimensions

Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch
Height8 Inch
Length14 Inch
Weight3.048 Pound
Height4 Inch
Width7 Inch
Depth4.5 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100893872001073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPAEndoilluminator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-09-15

Devices Manufactured by ELLEX ISCIENCE

00893872001059 - iTrack 250A2019-04-23 Canaloplasty Microcatheter Kit Kit Contents: (1) Canaloplasty Microcatheter iTrack 250A (1) Opthalmic Viscoinjector
00893872001073 - iLumin2019-04-23Optical Light Source- Fiberoptic Illuminator
00893872001073 - iLumin2019-04-23 Optical Light Source- Fiberoptic Illuminator

Trademark Results [iLumin]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ILUMIN
ILUMIN
97241924 not registered Live/Pending
Ilumin
2022-01-27
ILUMIN
ILUMIN
90249282 not registered Live/Pending
Gregorio Dynasty Inc.
2020-10-12
ILUMIN
ILUMIN
88524650 not registered Live/Pending
Inovelli, LLC
2019-07-19
ILUMIN
ILUMIN
75602697 2847612 Dead/Cancelled
ILUMIN SOFTWARE SERVICES, INC.
1998-12-10

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