GUDID 00840682113786

GE Medical Systems (Tianjin) Co., Ltd.

Full-body MRI system, superconducting magnet
Primary Device ID00840682113786
NIH Device Record Key3b474e5b-8bba-445b-9015-51d69b348574
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSIGNA Creator
Company DUNS421356265
Company NameGE Medical Systems (Tianjin) Co., Ltd.
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
GS100840682113786 [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 Date2019-03-15
Device Publish Date2016-08-01

Devices Manufactured by GE Medical Systems (Tianjin) Co., Ltd.

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00195278481382 - NA2022-09-16 SIGNA Artist Evo System Medical Device, MDR
00840682146302 - NA2022-03-15 SIGNA Prime System Medical Device
00195278372307 - NA2021-06-23 Voyager AIR Medical Device Assembly
00195278248923 - NA2021-05-04 SIGNA Voyager 1.5T Detachable Table Assembly
00195278124609 - NA2021-02-10 Kizuna System Medical Device Assembly-MDR

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