Duns Number:368444471
Device Description: DC-Air™ Docking Station is intended for use as a data transfer pathway between the DC-Air™ DC-Air™ Docking Station is intended for use as a data transfer pathway between the DC-Air™ Intraoral Sensor and a PC or laptop, and as a charging station for the DC-Air™ Intraoral Sensor.
Catalog Number
-
Brand Name
DC-Air™ Docking Station
Version/Model Number
WIOS-DS2
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
K211688,K211688
Product Code
MUH
Product Code Name
System, X-Ray, Extraoral Source, Digital
Public Device Record Key
f1133ed7-24de-4ac9-8b57-fe30235c946b
Public Version Date
May 03, 2022
Public Version Number
2
DI Record Publish Date
March 10, 2022
Package DI Number
06429810587091
Quantity per Package
1
Contains DI Package
06429810587039
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |