Duns Number:964053560
Device Description: Canalicular plug
Catalog Number
-
Brand Name
Comfortear Lacrisolve 180 Absorbable Punctum Plug
Version/Model Number
42702-175-03
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZU
Product Code Name
Plug, Punctum
Public Device Record Key
2559a390-968e-471a-991d-2fd563d2fede
Public Version Date
February 24, 2020
Public Version Number
1
DI Record Publish Date
February 14, 2020
Package DI Number
20810020080807
Quantity per Package
10
Contains DI Package
00810020080803
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 1369 |
U | Unclassified | 8 |