Duns Number:013469890
Device Description: Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged n Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged non-sterile plugs per poly bag. X-Small, 0.6mm.
Catalog Number
32-2005
Brand Name
Comfortear™
Version/Model Number
32-2005
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
79b22095-f765-4a2b-8de3-b4a6d43be3eb
Public Version Date
January 13, 2020
Public Version Number
2
DI Record Publish Date
January 03, 2019
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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 5 |