Duns Number:961027315
Device Description: ULTRASOUND GEL 60GM TUBE
Catalog Number
USG-60TB
Brand Name
CARDINAL HEALTH
Version/Model Number
USG-60TB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 30, 2020
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)
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
e7223d77-1630-4eba-b704-576c3aa1a465
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
August 15, 2016
Package DI Number
20885380066020
Quantity per Package
24
Contains DI Package
10885380066023
Package Discontinue Date
May 30, 2020
Package Status
Not 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 | 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 |