Duns Number:849234661
Device Description: EZ Scan 8oz Tube
Catalog Number
601002
Brand Name
E-Z-SCAN Low Viscosity UltraSound Gel
Version/Model Number
601002
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
-
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
2c5c468b-93a0-4677-bb28-f690ab93e6eb
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
30815112020546
Quantity per Package
12
Contains DI Package
10815112020542
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. | 28 |