Duns Number:002449593
Device Description: Ultrasonic Gel with Aloe Vera
Catalog Number
-
Brand Name
MedVat
Version/Model Number
MED-USG-CLEAR-8.5OZ-A
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
bbb467a9-60a9-4fba-b228-baecbf1ed85e
Public Version Date
October 12, 2021
Public Version Number
1
DI Record Publish Date
October 04, 2021
Package DI Number
10855683006835
Quantity per Package
12
Contains DI Package
00855683006838
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner 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 |