FDA.reportPublic FDA data

LACRIFLOW CL

Primary DI
04540778171398
Brand
LACRIFLOW CL
Company
KANEKA CORPORATION
Model
LF-CL090A
Device description
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.
Published
2017-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OKSLacrimal Stents And Intubation Sets

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKSLacrimal Stents And Intubation SetsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170247000Lacriflow CLKaneka Pharma America, LLC2017-04-18OKS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14540778171395PackageGS12In Commercial Distribution
04540778171398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454077817139514540778171395
04540778171398045407781713984540778171398

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal tubeAn implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length90Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the LACRIFLOW CL in the place avoiding direct sunlight at room temperature.

Contacts#

Phone, Email table
PhoneEmail
800-526-3522takuji.hasegawa@kaneka.com

Regulatory Flags#

DUNS number
690535406
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14993478010042LIXELLES-35N/A2024-10-25
14993478010059LIXELLES-15N/A2024-10-25
14993478010066LIXELLES-25N/A2024-10-25
14993478010110LIPOSORBERLA-15N/A2014-09-26
04540778177086i-ED COIL392-0615392-06152025-12-10
04540778177116i-ED COIL392-0720392-07202025-12-10
04540778193710i-ED COIL393-020320393-0203202025-12-10
04540778193727i-ED COIL393-020330393-0203302025-12-10
04540778171381LACRIFLOW CLLF-CL105A2017-06-01
04540778177031i-ED COIL392-0408392-04082025-06-26
14993478020225Lixelle S-25N/A2015-05-01
14993478020232Lixelle S-35N/A2015-05-01
14993478020218Lixelle S-15N/A2015-05-01
04540778177291i-ED COIL393-030510393-0305102024-10-25
04540778190412i-ED COIL390-0212390-02122024-10-25
04540778190429i-ED COIL393-030530393-0305302024-10-25
24993478010049LIXELLES-35N/A2024-10-25
04993478010052LIXELLES-15N/A2024-10-25
04993478010069LIXELLES-25N/A2024-10-25
04540778176485i-ED COIL390-01H4390-01H42023-07-27

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