Duns Number:690535406
Device Description: The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in c 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.
Catalog Number
-
Brand Name
LACRIFLOW
Version/Model Number
LF-R105A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K120886,K120886
Product Code
OKS
Product Code Name
Lacrimal Stents And Intubation Sets
Public Device Record Key
257d65a8-23e2-4ce0-a283-b69482c24ba8
Public Version Date
December 11, 2019
Public Version Number
5
DI Record Publish Date
September 17, 2016
Package DI Number
14540778140865
Quantity per Package
2
Contains DI Package
04540778140868
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 |