Duns Number:244261462
Device Description: DURAY V2, MOBILE DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
Catalog Number
-
Brand Name
DURAY
Version/Model Number
XR2012
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
K031118
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
889c2ac1-9e59-4434-a58c-322f8b044f83
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
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 | 150 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |
| U | Unclassified | 6 |