GUDID 00840682124591

GENERAL ELECTRIC COMPANY

MRI system application software
Primary Device ID00840682124591
NIH Device Record Keyb002c22c-8eb3-4ded-b673-1279ba85f02a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMP24 R03
Company DUNS160032025
Company NameGENERAL ELECTRIC COMPANY
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
GS100840682124591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUOTomographic imager combining emission computed tomography with nuclear magnetic resonance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-29

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