Not Applicable

GUDID 00840682105699

GENERAL ELECTRIC COMPANY

PET system
Primary Device ID00840682105699
NIH Device Record Key1dbf881a-de10-4c98-8c67-7cd58e3c06c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNot Applicable
Version Model Number5494440
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 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
GS100840682105699 [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 Date2016-08-01

On-Brand Devices [Not Applicable]

008406821056135265300-50
00840682115971Optima MR450w 1.5T
00840682115872Discovery MR750 3.0T
008406821056995494440

Trademark Results [Not Applicable]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOT APPLICABLE
NOT APPLICABLE
98469202 not registered Live/Pending
Veterans Plus Home Loans LLC
2024-03-26

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