Duns Number:019796106
Device Description: RVG CONNECT
Catalog Number
5313952
Brand Name
RVG CONNECT
Version/Model Number
RVG CONNECT
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
EAP
Product Code Name
UNIT, X-RAY, INTRAORAL
Public Device Record Key
71cbb347-51fe-4c51-bb9e-8fca7badaf39
Public Version Date
March 28, 2022
Public Version Number
7
DI Record Publish Date
January 15, 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 | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |