GUDID 00840682103763

GENERAL ELECTRIC COMPANY

MRI system coil, radio-frequency
Primary Device ID00840682103763
NIH Device Record Key62b79af8-998c-4ce5-b594-31bbb1921cf2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3.0T HD FLAT GEM TABLE BREAST ARRAY
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
GS100840682103763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, magnetic resonance, specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2016-08-01

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