Duns Number:043537671
Device Description: Ultrasound Procedure Kit
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
HCT9849-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
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
45145b26-853b-4c35-8067-1b718e479330
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 08, 2020
Package DI Number
M752HCT984915
Quantity per Package
50
Contains DI Package
M752HCT984910
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
OUTER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |