GUDID 00840682116084

GENERAL ELECTRIC COMPANY

MRI system coil, radio-frequency
Primary Device ID00840682116084
NIH Device Record Key9ce696d3-62f7-4391-8f03-f7554398b85a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5" ROUND COIL 1.5T
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
GS100840682116084 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2016-08-01

Devices Manufactured by GENERAL ELECTRIC COMPANY

00195278729224 - NA2023-09-28 PETMR PGR Upgrade Kit, MP24 to MP30
00195278648877 - NA2023-09-27 SIGNA PETMR System Medical Device Assembly - MDR
00195278596628 - NA2022-08-31 SIGNA Premier 3.0T Detachable Table Assembly- Wireless Gating
00195278596642 - NA2022-08-31 SIGNA Hero 3T Detachable Table Assembly- Wireless Gating
00195278486813 - NA2022-02-21 SIGNA Hero System Medical Device Assembly - MDR
00195278472083 - NA2022-01-10 SIGNA Hero 3T Detachable Table Assembly
00195278122643 - NA2021-05-18 1.5T Signa HDxt Upgrade Kit Medical Device, MDR
00195278005502 - NA2020-08-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.