GUDID 00840682144261

GENERAL ELECTRIC COMPANY

Full-body MRI system, superconducting magnet
Primary Device ID00840682144261
NIH Device Record Key3e355f0e-3f4d-4c36-a1ea-3985cb3e3707
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5815748
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 Batchfalse
Serial Numbertrue
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
GS100840682144261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, nuclear magnetic resonance imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-26
Device Publish Date2019-07-18

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