Duns Number:036623932
Device Description: 2% Chlorhexidine Gluconate - use prior to restorative preparations of crowns and composite 2% Chlorhexidine Gluconate - use prior to restorative preparations of crowns and composites. Restorative kit includes (4) 1.2ml prefilled syringes & 40 Sol-u-Flo tips.
Catalog Number
-
Brand Name
CHX
Version/Model Number
502450
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
-
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
KJJ
Product Code Name
Cleanser, Root Canal
Public Device Record Key
950a46e6-c59f-43f3-81b3-6c9f3d7ebe05
Public Version Date
September 13, 2021
Public Version Number
4
DI Record Publish Date
July 31, 2018
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 | 316 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |
| U | Unclassified | 36 |