Duns Number:690535406
Device Description: The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, i 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.
Catalog Number
-
Brand Name
LACRIFLOW CL
Version/Model Number
LF-CL105A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170247,K170247
Product Code
OKS
Product Code Name
Lacrimal Stents And Intubation Sets
Public Device Record Key
edd4ddd2-41a4-47cf-8730-7b6cfe7bc899
Public Version Date
December 11, 2019
Public Version Number
5
DI Record Publish Date
June 01, 2017
Package DI Number
14540778171388
Quantity per Package
2
Contains DI Package
04540778171381
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1041 |
| U | Unclassified | 1 |