Duns Number:175899459
Device Description: SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON SIEMENS IMAGING SYSTEM
Catalog Number
R10439011
Brand Name
N/A
Version/Model Number
R10439011
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161700
Product Code
OWQ
Product Code Name
Reprocessed intravascular ultrasound catheter
Public Device Record Key
99e07352-060e-47e6-be10-a156208c222a
Public Version Date
August 14, 2019
Public Version Number
5
DI Record Publish Date
February 15, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2763 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1372 |
| U | Unclassified | 20 |