Duns Number:041810693
Device Description: LacriCATH kit DCR508-UNIT contains one lacrimal duct catheter 5mm, one AQL 1015 inflation LacriCATH kit DCR508-UNIT contains one lacrimal duct catheter 5mm, one AQL 1015 inflation device, and one LIS052 STENTube intubation device.
Catalog Number
-
Brand Name
LacriCATH
Version/Model Number
DCR508-UNIT
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
K113867
Product Code
OKS
Product Code Name
Lacrimal Stents And Intubation Sets
Public Device Record Key
54871cd8-c5e8-4100-b37e-8b1625769563
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
May 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 168 |
| U | Unclassified | 8 |