Duns Number:413819707
Device Description: Intended to be used during peripheral nerve block procedures. Tracks the position of the B Intended to be used during peripheral nerve block procedures. Tracks the position of the B.Braun Onvision needle tip position on the ultrasound image by overlaying a circle at the given location.
Catalog Number
453561943492
Brand Name
Onvision system
Version/Model Number
Onvision system
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
K192914
Product Code
IYO
Product Code Name
System, Imaging, Pulsed Echo, Ultrasonic
Public Device Record Key
e9b9594c-1821-48f5-86b4-57699aeceee9
Public Version Date
July 26, 2022
Public Version Number
2
DI Record Publish Date
August 07, 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. | 349 |