Duns Number:019796106
Device Description: RVG 6200 #1 WITH RVG CONNECT FOR US
Catalog Number
5319462
Brand Name
RVG 6200
Version/Model Number
RVG 6200
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
c7def2e7-4d96-4ff3-9c62-f25c73e3346d
Public Version Date
March 28, 2022
Public Version Number
6
DI Record Publish Date
January 10, 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 |