Duns Number:812762226
Device Description: PCL-PLUG 2MM X 0.3MM
Catalog Number
-
Brand Name
PCL-PLUG 2MM X 0.3MM
Version/Model Number
EPLUG3
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
fb4d8a18-fb3a-4204-a41f-de59e7a8b911
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
10848782023810
Quantity per Package
10
Contains DI Package
00848782023813
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 | 300 |
2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
U | Unclassified | 19 |