Onvision system

GUDID 00884838090668

The Onvision system is intended to be used during peripheral nerve block procedures. It tracks the position of the B.Braun Stimuplex Onvision needle tip, for viewing the needle tip position on the ultrasound image by overlaying a circle at the given location.

Philips Medical Systems Nederland B.V.

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Primary Device ID00884838090668
NIH Device Record Keye9b9594c-1821-48f5-86b4-57699aeceee9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnvision system
Version Model Number45356194349
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838090668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-07

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