Duns Number:688209954
Device Description: - Extraoral source x-ray systemBattery Input: 22.2V, 1AOutput Rating: 210WkVp: 70kVmA: 3mA - Extraoral source x-ray systemBattery Input: 22.2V, 1AOutput Rating: 210WkVp: 70kVmA: 3mASec: 0.02 - 0.5sec
Catalog Number
ECO-ER-CAT-001DT
Brand Name
N/A
Version/Model Number
DT-703
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K221233
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
2415011d-43c2-4544-bd01-286c80303771
Public Version Date
July 13, 2022
Public Version Number
1
DI Record Publish Date
July 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |