4D View

GUDID 00840682137621

GE Healthcare Austria GmbH & Co OG

Ultrasound imaging system operation software
Primary Device ID00840682137621
NIH Device Record Key11458ee2-baa3-4ee7-aed4-eedbefd1d97a
Commercial Distribution StatusIn Commercial Distribution
Brand Name4D View
Version Model Number18
Company DUNS300599979
Company NameGE Healthcare Austria GmbH & Co OG
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100840682137621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-01-22
Device Publish Date2018-10-03

On-Brand Devices [4D View]

0084068213762118
0084068212278817
0084068210278016

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