Duns Number:001406024
Device Description: PUNCTAL OCCLUDER BULK LARGE 0.7MM-0.85MM
Catalog Number
A14-206BN
Brand Name
PLUS
Version/Model Number
A14-206BN
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
63710d28-a234-4cc7-a3e8-544251e29323
Public Version Date
February 10, 2022
Public Version Number
1
DI Record Publish Date
February 02, 2022
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 | 441 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |
U | Unclassified | 34 |