Duns Number:191036107
Device Description: Cavity Varnish, Dental.
Catalog Number
RCG
Brand Name
Resolve Cleansing Gel
Version/Model Number
Single - Pink
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PME
Product Code Name
External Cleaning Solution
Public Device Record Key
1648ef33-2cdd-4bef-bc9c-5f4b6a47ad87
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 04, 2016
Package DI Number
D820RCG1
Quantity per Package
2
Contains DI Package
D820RCG0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |