Duns Number:828918164
Device Description: Non-Sterile Ultrasound Gel High Viscosity
Catalog Number
386
Brand Name
EcoVue HV
Version/Model Number
386
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
-
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
MUI
Product Code Name
Media, coupling, ultrasound
Public Device Record Key
d54785f2-7625-4346-8364-d6cc27b4cd6d
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 21, 2020
Package DI Number
20851809002375
Quantity per Package
6
Contains DI Package
10851809002378
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |