Duns Number:013469890
Device Description: Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomi Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Large, 0.9 mm.
Catalog Number
24-2008
Brand Name
Comfortear™
Version/Model Number
24-2008
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
-
Product Code
LZU
Product Code Name
Plug, Punctum
Public Device Record Key
4859a2b2-5283-4870-bdaa-b737a6df11da
Public Version Date
January 13, 2020
Public Version Number
2
DI Record Publish Date
January 03, 2019
Package DI Number
30810003223549
Quantity per Package
2
Contains DI Package
10810003223545
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 5 |