LACRIFLOW CL

GUDID 14540778171395

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
Primary Device ID14540778171395
NIH Device Record Key3b1bdab1-a144-4de2-9e1a-7087fc4b1f61
Commercial Distribution StatusIn Commercial Distribution
Brand NameLACRIFLOW CL
Version Model NumberLF-CL090A
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 Latextrue
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

Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 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
GS104540778171398 [Primary]
GS114540778171395 [Package]
Contains: 04540778171398
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

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