Duns Number:078474365
Device Description: EdgeEndo sodium hypochlorite is a sodium hypochlorite solution in water with wetting agent EdgeEndo sodium hypochlorite is a sodium hypochlorite solution in water with wetting agents to lower surface tension.
Catalog Number
-
Brand Name
EdgeEndo Sodium Hypochloite
Version/Model Number
EENAOCL
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
ea2b930b-22cc-4752-a006-acf5ee598f9f
Public Version Date
October 05, 2018
Public Version Number
3
DI Record Publish Date
September 28, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |
| U | Unclassified | 3 |