Duns Number:315666321
Device Description: sealant, pit and fissure and conditionar
Catalog Number
66040373
Brand Name
VENUS Diamond FLOW PLT 20x0,20g - A4
Version/Model Number
66040373
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K091635
Product Code
EBC
Product Code Name
SEALANT, PIT AND FISSURE, AND CONDITIONER
Public Device Record Key
8406747e-bd7d-4dca-a323-5a9ee2904360
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 5609 |