Duns Number:002449593
Device Description: Aquasonic Clear Ultrasound Electrode gel, 5 Liter Cubetainer
Catalog Number
03-54
Brand Name
AQUASONIC CLEAR
Version/Model Number
ULTRASOUND GEL
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MUI
Product Code Name
Media,Coupling,Ultrasound
Public Device Record Key
c3b3ea6d-52b0-42e5-b258-752205b8c990
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
December 06, 2016
Package DI Number
10855683006484
Quantity per Package
4
Contains DI Package
00855683006487
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |