Duns Number:267799927
Device Description: Handheld Ultrasound Scanner with exchangeable probes
Catalog Number
-
Brand Name
U-Lite
Version/Model Number
EXP
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171164
Product Code
IYN
Product Code Name
System, Imaging, Pulsed Doppler, Ultrasonic
Public Device Record Key
885b2bb0-deb9-49e4-9cc2-bb2f48c74293
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 06, 2018
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. | 17 |