LACRIFLOW CL

Primary DI
14540778171395
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690535406
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
04540778171398LACRIFLOW CLLF-CL090A2017-06-01
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

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