Duns Number:069261402
Device Description: Vascular Doppler system for arterial and venous testing capabilities with Smart-XT-Link so Vascular Doppler system for arterial and venous testing capabilities with Smart-XT-Link software.
Catalog Number
Smartdop XT
Brand Name
Smartdop XT
Version/Model Number
Smartdop XT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K131623
Product Code
JOP
Product Code Name
Transducer, Ultrasonic
Public Device Record Key
fc7e8653-54e9-45fc-86f9-ff7a88cadc5e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 25, 2016
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |