DEVICE: LACRIFLOW (04540778140868)
Device Identifier (DI) Information
LACRIFLOW
LF-R105A
In Commercial Distribution
KANEKA CORPORATION
LF-R105A
In Commercial Distribution
KANEKA CORPORATION
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.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17003 | Lacrimal tube |
An 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).
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OKS | Lacrimal Stents And Intubation Sets |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 105 Millimeter |
Device Record Status
257d65a8-23e2-4ce0-a283-b69482c24ba8
September 11, 2023
6
September 17, 2016
September 11, 2023
6
September 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14540778140865 | 2 | 04540778140868 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-526-3521
takuji.hasegawa@kaneka.com
takuji.hasegawa@kaneka.com