LACRIFLOW

GUDID 04540778140875

The LACRIFLOW 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 ID: 04540778140875
• NIH Device Record Key: 6834f182-0142-422d-ab8d-5c67edd6da20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LACRIFLOW
• Version Model Number: LF-R090A
• Company DUNS: 690535406
• Company Name: KANEKA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com

Device Dimensions

• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04540778140875 [Primary]
GS1	14540778140872 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120886

FDA Product Code

• OKS: Lacrimal Stents And Intubation Sets

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-17

On-Brand Devices [LACRIFLOW]

• 04540778140875: The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in cases o
• 04540778140868: The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in cases o