Duns Number:430142798
Device Description: The RiX 70 DC Mobile is an X-Ray source to produce intraoral images for the diagnosis of t The RiX 70 DC Mobile is an X-Ray source to produce intraoral images for the diagnosis of teeth and adjacent structures.
Catalog Number
RIX70DC-000
Brand Name
RiX70 DC
Version/Model Number
Mobile version
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
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
3592a5c2-ba8b-4d13-a55c-cba8b1baa70b
Public Version Date
March 28, 2022
Public Version Number
2
DI Record Publish Date
September 07, 2020
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. | 16 |