Duns Number:108999095
Device Description: Adstation Oto-Xen/Throat-LED, ,9003W/Spec Disp, WB, EU
Catalog Number
5611X-36L8EUW
Brand Name
Diagnostix™
Version/Model Number
5611X-36L8EUW
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
a9135978-4454-46b0-87c9-d7a18c95a445
Public Version Date
January 10, 2020
Public Version Number
1
DI Record Publish Date
January 02, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2395 |
2 | A medical device with a moderate to high risk that requires special controls. | 1769 |