LACRIFLOW CL

GUDID 04540778171381

The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction.

KANEKA CORPORATION

Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube
Primary Device ID04540778171381
NIH Device Record Keyedd4ddd2-41a4-47cf-8730-7b6cfe7bc899
Commercial Distribution StatusIn Commercial Distribution
Brand NameLACRIFLOW CL
Version Model NumberLF-CL105A
Company DUNS690535406
Company NameKANEKA CORPORATION
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 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

Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com
Phone800-526-3522
Emailtakuji.hasegawa@kaneka.com

Device Dimensions

Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter
Length105 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS104540778171381 [Primary]
GS114540778171388 [Package]
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OKSLacrimal Stents And Intubation Sets

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-11
Device Publish Date2017-06-01

On-Brand Devices [LACRIFLOW CL]

14540778171395The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in case
04540778171381The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in case

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.