GUDID 00195278472083

SIGNA Hero 3T Detachable Table Assembly

GENERAL ELECTRIC COMPANY

Full-body MRI system, superconducting magnet
Primary Device ID00195278472083
NIH Device Record Key368155d3-d8e7-41ad-852f-da06351bdb57
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6265300-20
Company DUNS160032025
Company NameGENERAL ELECTRIC COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278472083 [Primary]

FDA Product Code

KXJTable, radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-10
Device Publish Date2021-12-31

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 - NA2022-01-10SIGNA Hero 3T Detachable Table Assembly
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

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