Duns Number:961027315
Device Description: ULTRASOUND GELWater SolubleAcoustically correctNon-irritatingCardinal Health Ultrasound Ge ULTRASOUND GELWater SolubleAcoustically correctNon-irritatingCardinal Health Ultrasound Gel is an acoustically correct, dye-free and greaseless echogenic medium used for all ultrasound procedures.
Catalog Number
USG-5L
Brand Name
CARDINAL HEALTH
Version/Model Number
USG-5L
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
12d9b746-3a78-428b-9645-112938bfe129
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
August 15, 2016
Package DI Number
50885380066045
Quantity per Package
4
Contains DI Package
10885380066047
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |