Duns Number:079686615
Catalog Number
MUS05170
Brand Name
Medisono
Version/Model Number
INTRAOPERATIVE MODEL 6CT-A FOR MEDISONO P25 EXPERT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IYN
Product Code Name
System, imaging, pulsed doppler, ultrasonic
Public Device Record Key
5f631d3d-5c42-4d27-b61f-f4f22828ffc0
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
December 28, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 135 |