iTrack 250A 200478

GUDID 00893872001059

Canaloplasty Microcatheter Kit Kit Contents: (1) Canaloplasty Microcatheter iTrack 250A (1) Opthalmic Viscoinjector

ELLEX ISCIENCE

Ophthalmic infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Primary Device ID00893872001059
NIH Device Record Key099ce6e6-853e-4275-809e-e2c538f9da0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTrack 250A
Version Model NumberiTrack 250A
Catalog Number200478
Company DUNS079755637
Company NameELLEX ISCIENCE
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound
Outer Diameter250 Micrometer
Length12.5 Centimeter
Weight0.535 Pound

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100893872001059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HMXCannula, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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